A Phase 3 interventional study of Capecitabine and Temozolomide (TMZ) in Gastroenteropancreatic Neuroendocrine Tumors, sponsored by Tata Memorial Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Tata Memorial Hospital · Phase 3, Interventional, and Treatment
The goal of this Phase III randomized controlled, open-label clinical trial is to evaluate the efficacy and safety of adding peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE to standard-of-care chemotherapy (CAPTEM), compared with CAPTEM alone, in adults with unresectable or metastatic, WHO Grade 3 well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with a Ki-67 index of >20% to \<55% and positive somatostatin receptor imaging.
The main questions it aims to answer are:
Researchers will compare Arm A (CAPTEM alone) with Arm B (PRRT plus CAPTEM) to evaluate differences in progression-free survival, disease control, overall survival, toxicity, and quality of life between the two treatment groups. Participants will be randomly assigned in a 1:1 ratio to either treatment arm.
Participants will:
The TRINITY Trial is a Phase III, randomized, controlled, open-label clinical trial designed to evaluate the efficacy and safety of combining peptide receptor radionuclide therapy (PRRT) with standard-of-care chemotherapy (CAPTEM) compared with CAPTEM chemotherapy alone in patients with well-differentiated Grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Gastroenteropancreatic neuroendocrine tumors comprise a heterogeneous group of neoplasms with variable biological behavior and treatment response. The World Health Organization classification recognizes well-differentiated Grade 3 neuroendocrine tumors as a distinct subgroup based on a Ki-67 proliferation index greater than 20%, differentiating them from poorly differentiated neuroendocrine carcinomas. Patients with metastatic or unresectable well-differentiated Grade 3 GEP-NETs represent a clinically challenging population because robust prospective evidence guiding the optimal sequencing or combination of systemic therapies remains limited.
CAPTEM, a combination of capecitabine and temozolomide, is an established chemotherapy regimen used in the management of neuroendocrine tumors. Capecitabine is an oral prodrug that is converted to 5-fluorouracil and exerts antitumor activity through inhibition of thymidylate synthase and disruption of DNA synthesis. Temozolomide is an oral alkylating agent that causes DNA damage. The combination provides a complementary pharmacological approach and has demonstrated activity in advanced neuroendocrine tumors, including well-differentiated Grade 3 disease.
PRRT is a targeted radionuclide treatment that uses a radiolabeled somatostatin analogue to selectively deliver therapeutic radiation to tumor cells expressing somatostatin receptors (SSTR). Lutetium-177 (\^177Lu)-DOTATATE is administered intravenously and binds to somatostatin receptors expressed on neuroendocrine tumor cells, resulting in delivery of beta-particle radiation to the targeted tumor tissue. The study population is selected for appropriate SSTR expression and FDG avidity to identify tumors for which PRRT is considered clinically relevant. The combination of PRRT with chemotherapy is also referred to as peptide receptor chemoradionuclide therapy (PRCRT).
The rationale for the TRINITY Trial is based on the established clinical activity of both CAPTEM and PRRT and the reported clinical experience with their combination in neuroendocrine tumors. Although both approaches are used as standard treatment strategies in appropriate patients, there is a need for prospective randomized evidence directly comparing CAPTEM alone with the combination of PRRT and CAPTEM specifically in well-differentiated Grade 3 GEP-NETs. The trial is therefore designed to provide comparative evidence regarding disease control, survival, treatment-related toxicity, and patient-reported quality of life.
The study is being conducted at Adavanced Centre for Treatment, Education and Research in Cancer, Kharghar and Tata Memorial Hospital. Patients considered for participation are evaluated through the multidisciplinary neuroendocrine tumor clinic and relevant gastrointestinal, hepatopancreatobiliary, and oncology disease management groups. Potentially eligible patients are assessed clinically and undergo the investigations required for confirmation of study eligibility and baseline characterization. After confirmation of eligibility and completion of the informed consent process, participants are randomized to one of two treatment groups.
Randomization is performed in a 1:1 ratio using a centralized, web-based randomization system. Permuted block randomization with block sizes of 2 and 4 is used, with stratification according to the primary tumor site, namely pancreatic versus small-intestinal primary tumor. The allocation sequence is generated by an independent statistician. As this is an open-label study, participants, treating physicians, data managers, and statistical analysts are not masked to treatment assignment.
Participants randomized to Arm A receive CAPTEM alone. Capecitabine is administered orally at a dose of 1500 mg/m² twice daily for 14 days, followed by a 2-week rest period. Temozolomide is administered orally on Days 10 through 14 at a dose of 20 mg/m² once daily for 5 days. The protocol permits a maximum of 12 CAPTEM cycles. Capecitabine tablets are administered orally and are swallowed whole with water, according to the administration instructions specified in the protocol. Treatment-related toxicities are monitored clinically and through laboratory investigations, with appropriate management according to clinical requirements and the study protocol.
Participants randomized to Arm B receive PRRT with \^177Lu-DOTATATE in combination with CAPTEM. \^177Lu-DOTATATE is administered intravenously at a standard dose in the range of 180-200 mCi per PRRT session. Four standard PRRT sessions are planned, with an interval of approximately 6-8 weeks between sessions. A gap of approximately 1-2 weeks is maintained between PRRT and CAPTEM administration. The treatment sequence consists of one PRRT session followed by two CAPTEM cycles, with subsequent PRRT and CAPTEM administrations continuing according to the protocol-defined schedule. CAPTEM dosing in the combination arm follows the same regimen used in Arm A.
Additional PRRT may be considered in selected participants who demonstrate partial response following completion of the initial four PRRT sessions, in accordance with established practice standards and clinical assessment. The protocol permits up to a maximum of eight PRRT sessions and up to 12 CAPTEM cycles. Decisions regarding continuation or additional treatment are based on clinical assessment, disease status, treatment tolerance, and the protocol-defined treatment framework.
PRRT administration is conducted in designated radioisotope therapy facilities at Tata Memorial Hospital and ACTREC. Appropriate radiation safety procedures are followed during administration and post-treatment monitoring. Following administration of \^177Lu-DOTATATE, radiation exposure is monitored at regular intervals, and participants remain in the designated isolation/radiation safety facility until the measured exposure rate satisfies the applicable institutional discharge criteria. Post-therapy imaging is performed to assess localization of the administered radiopharmaceutical. Planar imaging is obtained within 24 hours before discharge, and additional imaging may be performed at approximately 48 and 96-168 hours for dosimetric assessment of radiation distribution to tumor and non-target organs, as per institutional practice.
After completion of post-therapy assessment, participants are discharged with treatment and follow-up documentation and advice as specified by the Nuclear Medicine team. Radiation safety procedures are implemented in accordance with institutional requirements. In the event of a medical emergency, appropriate medical care takes priority and radiation precautions are not intended to delay necessary emergency treatment.
Throughout active treatment, participants undergo clinical and laboratory monitoring for treatment tolerance, disease status, and adverse events. Laboratory monitoring includes hematological, renal, hepatic, and electrolyte parameters as clinically appropriate. Adverse events are documented and graded according to the toxicity grading system specified in the protocol. Particular attention is given to clinically significant and severe treatment-related toxicities, including hematological, gastrointestinal, hepatic, renal, and other treatment-associated toxicities. Serious adverse events are documented and reported according to applicable institutional and regulatory requirements.
Tumor assessment is performed using anatomical and functional imaging. FDG PET/CT and Ga-68 DOTA PET/CT are incorporated into the disease assessment strategy because the study population is characterized by both somatostatin receptor expression and FDG uptake. Imaging is performed at protocol-defined intervals and is used to assess disease status and treatment response. In participants receiving PRRT, additional FDG PET/CT and Ga-68 DOTA PET/CT assessments are performed approximately 3-4 weeks after the second and fourth PRRT sessions. Response is evaluated using RECIST 1.1 criteria along with the functional imaging information obtained during follow-up.
Participants continue to be followed after completion of protocol-directed treatment. Clinical follow-up is conducted on an outpatient basis approximately every three months during the first two years and every six months thereafter until disease progression or death. Imaging assessments are performed approximately every 3-4 months during the first two years and subsequently every 6-7 months until progression or death, in accordance with the study protocol and standard institutional follow-up practices. The PRRT-containing arm has additional imaging following the specified PRRT sessions as described above.
Health-related quality of life is assessed using validated European Organisation for Research and Treatment of Cancer questionnaires, including the EORTC QLQ-C30 and the disease-specific EORTC QLQ-GINET21. These questionnaires are administered at protocol-defined time points to evaluate patient-reported health status, symptoms, functioning, and quality-of-life parameters during treatment and follow-up.
The primary efficacy analysis evaluates progression-free survival between the two randomized treatment groups. Progression-free survival is assessed from the relevant baseline/time point until documented disease progression or death, according to the protocol-defined assessment methodology. Disease response and disease control are assessed using the protocol-specified response criteria and imaging schedule. Overall survival is assessed during longitudinal follow-up. Safety analyses include the incidence and severity of adverse events, with particular evaluation of severe treatment-related toxicity.
The planned sample size is 123 participants. The sample size calculation is based on the primary objective of assessing the difference in one-year progression-free survival between the CAPTEM-alone and PRRT-plus-CAPTEM groups. The protocol assumes a one-year PFS rate of 42% for the CAPTEM-alone arm and an anticipated one-year PFS rate of 62% with the addition of PRRT. The study is designed to observe approximately 90 events, considering an accrual period of four years, a follow-up period of one year, a two-sided alpha of 5%, statistical power of 80%, and a 10% dropout rate. The sample size was calculated using a log-rank test with PASS Version 21.0.3.
For efficacy analyses, patients lost to follow-up before the first post-baseline assessment are excluded from the primary efficacy analysis, and no imputation is planned for missing efficacy data. Safety analyses include all observed safety information from participants who receive at least one dose of protocol treatment, whether CAPTEM, PRRT, or both. Adverse events are summarized according to system organ class, severity/grade, and attribution. The proportion of participants experiencing Grade 3 or higher adverse events is reported with exact 95% confidence intervals, together with descriptive summaries of safety outcomes. Serious adverse events are evaluated and reported separately.
Study data are monitored throughout trial conduct. The Principal Investigator monitors study data and completion on a monthly basis. Annual study continuation reports are prepared and submitted to the Institutional Ethics Committee. An independent monitoring committee associated with the Data and Safety Monitoring Committee reviews trial conduct and study data in accordance with the institutional protocol.
The study is intended to establish prospective randomized evidence regarding the comparative use of CAPTEM alone versus PRRT combined with CAPTEM in well-differentiated Grade 3 GEP-NETs. By incorporating efficacy, safety, longitudinal survival follow-up, imaging-based disease assessment, and patient-reported quality-of-life evaluation, the trial aims to provide a comprehensive assessment of the clinical impact of adding PRRT to standard CAPTEM chemotherapy in this patient population.
72 studies on the registry are indexed under Gastro-enteropancreatic neuroendocrine tumor; 24 are open to participants now.
This study's planned enrollment of 123 is above the median of 53 across 48 interventional studies indexed under Gastro-enteropancreatic neuroendocrine tumor.
Browse Gastro-enteropancreatic neuroendocrine tumor studies →Tata Memorial Hospital is the lead sponsor of 99 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive CAPTEM chemotherapy alone. Capecitabine 1500 mg/m² orally twice daily on Days 1-14 followed by a 14-day rest period. Temozolomide 200 mg/m² orally once daily on Days 10-14. Treatment is repeated every 28 days for up to 12 cycles according to protocol and standard-of-care practice
Drug: Capecitabine · Drug: Temozolomide (TMZ)
Participants receive peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE (180-200 mCi intravenously every 6-8 weeks for 4 cycles) in combination with CAPTEM chemotherapy. Each PRRT session is followed by CAPTEM according to the study schedule
Drug: Capecitabine · Drug: Temozolomide (TMZ) · Drug: Lutetium Lu 177 Dotatate
Oral capecitabine 1500 mg/m² twice daily within 15 minutes of food on Days 1-14, followed by a 2-week rest, for up to 12 cycles. 500 mg tablets.
Oral temozolomide 20 mg/m² once daily at bedtime on Days 10-14 of each capecitabine cycle, taken on an empty stomach, for up to 12 cycles.
180-200 mCi diluted in 100 mL normal saline, given intravenously over 30 minutes with a co-infusion of 10% amino acids (Aminoven 1000 mL) for kidney protection. Given every 6-8 weeks for 4 sessions; up to 8 sessions in patients with a partial response.
1-Year Progression-Free Survival (PFS)
Proportion of patients who remain free from disease progression at 1 year following randomization, comparing PRRT plus CAPTEM versus CAPTEM alone in patients with well-differentiated Grade 3 gastroenteropancreatic neuroendocrine tumors. Disease progression will be assessed using RECIST 1.1 criteria.
Time frame: 1 year after randomization
Disease Control Rate (DCR)
Percentage of patients achieving complete response, partial response, or stable disease according to RECIST 1.1 criteria in the two treatment arms.
Time frame: 1 year after randomization
Overall Survival (OS)
Comparison of overall survival between patients receiving PRRT plus CAPTEM and those receiving CAPTEM alone. Overall survival is defined as the time from randomization to death from any cause.
Time frame: From randomization until death or end of study follow-up (up to 5 years)
Incidence of Grade 3 or Higher Treatment-Related Toxicities
Comparison of the incidence and severity of treatment-related adverse events between the two study arms, with particular focus on Grade 3 or higher toxicities as assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Throughout treatment and up to 30 days after completion/discontinuation of protocol treatment
Change from baseline in global health status/quality of life, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 (version 3.0) is a 30-item cancer-specific quality-of-life questionnaire. It has a global health status/quality of life scale, five functional scales, three symptom scales and six single items. Raw scores are linearly transformed to a 0-100 scale (minimum 0, maximum 100). For the global health status/quality of life scale and the functional scales, higher scores mean better quality of life and functioning (a better outcome). For the symptom scales and single items, higher scores mean more severe symptoms (a worse outcome). The change from baseline in the global health status/quality of life score will be compared between the two arms.
Time frame: Baseline up to 12 months (Arm A: every 4-6 months; Arm B: before each PRRT session; both arms: at scheduled follow-up visits)
Change from baseline in symptom scores, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Neuroendocrine Tumour module (EORTC QLQ-GI.NET21)
he EORTC QLQ-GI.NET21 is a 21-item questionnaire for patients with gastrointestinal neuroendocrine tumours. It has five multi-item scales (endocrine symptoms, gastrointestinal symptoms, treatment-related symptoms, social function and disease-related worries) and single items, including muscle/bone pain and body image. Each item is answered on a 4-point scale, and scores are linearly transformed to a 0-100 scale (minimum 0, maximum 100). Higher scores mean more severe symptoms or problems (a worse outcome). The change from baseline in each scale score will be compared between the two arms.
Time frame: Baseline up to 12 months (Arm A: every 4-6 months; Arm B: before each PRRT session; both arms: at scheduled follow-up visits)
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2031, 60 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lutetium Lu 177 dotatate
Gastro-enteropancreatic neuroendocrine tumor →
Tata Memorial Hospital