A Phase 3 interventional study of Nelfinavir and Cisplatin in Carcinoma Cervix,Stage III, sponsored by Tata Memorial Hospital. Completed at 1 site in India. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Tata Memorial Hospital · Phase 3, Interventional, and Treatment
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Among 27 studies in Uterine Cervical Neoplasms by Tata Memorial Hospital — 9 open to participants now, 9 under way, 1 of them phase 3. Uterine Cervical Neoplasms · Tata Memorial Hospital.
Among the 27 studies in Uterine Cervical Neoplasms by Tata Memorial Hospital, this one is the 8th largest by enrollment of the 17 interventional ones that give a count, is one of 5 that started in 2018, is one of 5 in phase 3, and was the 17th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →9 of the 27 studies in Uterine Cervical Neoplasms by Tata Memorial Hospital are open now, in 3 countries. Recruiting first, the newest first:
Tata Memorial Hospital · Sites in India, Japan, Thailand
Women only
Tata Memorial Hospital · Sites in India
Ages 18+ · Women only
Tata Memorial Hospital · Sites in India
Ages 18–75 · Women only
Tata Memorial Hospital · Sites in India
Ages 18–70 · Women only
Tata Memorial Hospital · Sites in India
By country, each count listing its studies:
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 348 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 316 across the 17 interventional studies, 325 across the 10 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Tata Memorial Hospital is the lead sponsor of 99 studies on the registry; 21 are open to participants now.
2 of the studies in Uterine Cervical Neoplasms by Tata Memorial Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06644846Tata Memorial HospitalSpatially Fractionated Radiation Treatment for Gynaecological Cancers | 2027-02-28 |
| NCT07400809Tata Memorial HospitalCervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study. | 2027-06-14 |
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Among the 27 studies in Uterine Cervical Neoplasms by Tata Memorial Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The primary aim of the trial is to study the impact of nelfinavir on 3 year disease free survival in patients with advanced carcinoma of cervix receiving standard chemoradiation (Cisplatin and Radiotherapy).
There will be two study groups. One group will receive standard treatment (concurrent chemoradiation and brachytherapy) \& other group will receive nelfinavir 5-7 days prior to standard treatment (chemoradiation \& brachytherapy).
The trial is a single centre open label randomized unblinded phase-III study to evaluate the efficacy of an investigational drug (Nelfinavir) in combination with standard therapy consisting of weekly cisplatin and pelvic EBRT in cohort of patients diagnosed with FIGO 2018 stage III Carcinoma cervix.
Patient registration / randomization procedure
348 Patients will be accrued from the Gynaec Oncology Service of Tata Memorial Centre, Mumbai. A study coordinator at TMC will coordinate the accrual and study process and ensure prompt accrual and proper documentation. Eligibility will be checked based on the selection criteria and written informed consent will be obtained prior to randomization. Patients will be given appropriate time to decide for participation. Randomization will be based on a chart prepared with the help of software using a random sorting algorithm. A screening log will be maintained and include the details of all patients screened.
There are two study arms. In Experimental arm (Nelfinavir arm) 174 patients will be accrued \& in Control arm (Standard Arm) 174 patients will be accrued.
If patient is randomized to standard arm patient will receive concurrent chemoradiation and brachytherapy. If patient is randomized to nelfinavir arm then nelfinavir will be started at the dose of 1250 mg bid 5-7 days prior to standard treatment (chemoradiation \& brachytherapy)
Therapeutic regimens
Cisplatin
Cisplatin will be administered on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT. Patient will be premedicated with I.V Ondansetron to prevent emesis. Pre chemotherapy and post chemotherapy, patient will be administered IV fluids for effective renal clearance of cisplatin.
Nelfinavir
Nelfinavir will be taken orally with food, because the bioavailability increases under the influence of food. Treatment will start 5-7 days before start of chemo radiation and will continue for the duration of external beam radiotherapy ( no Nelfinavir on weekends or radiation breaks). We will be using a dose of 1250mg BID along with weekly cisplatin, 40mg /m2. All patients will undergo blood sugar evaluation, ECG and Lipid Profile at baseline, treatment completion and at 6 months of follow up. Blood sugars will also be monitored at every 2 weeks while on chemoradiation.
Administration of Pelvic EBRT and Brachytherapy
All patients will undergo baseline MRI of abdomen and pelvis (T2+ T1 with and without contrast+ diffusion and perfusion MRI). Extra sequence acquisition as part of research (like BOLD MRI will be performed on only 60 patients ( 30 in each arm). As MRI will be used for response assessment and brachytherapy planning, in addition to axial images saggital and coronal images will be obtained at each examination. Pelvic EBRT will delivered by standard 4 field technique using 6MV/15 MV photon beams. Prior to delivery of radiation, patients will be simulated by CT simulator for planning the beam arrangements. Total dose of pelvic EBRT will be 45- 50Gy/23-25 #/5 weeks, and involved nodes will receive a total EBRT dose of 55 - 60Gy. The prescribed dose will be specified according to ICRU 50 guidelines. All patients will be treated with 3D conformal external radiation with target delineation and multileaf collimator leaf shaping. Biopsies will be performed at two different time points. One prior to treatment initiation and another before last dose of concurrent cisplatin. Patients will be evaluated by the concerned investigators on a weekly basis during radiation therapy and all the toxicities will be documented according to the CTCAE V4.0.
All patients will undergo image based brachytherapy. Standard guidelines for reporting or prescription will be followed.
Translational research studies
Five ml blood sample and tumor biopsies will be taken prior to nelfinavir use, and after EBRT on the day of 1st ICRT. Phosphorylated Akt and total Akt will be determined using flowcytometry/western blot method, as a marker of penetration of the drug into the tumor. The level of phosphorylated Akt will be correlated with tumour response as measured by PET/CT \& MRI (changes in SUV max as measured by PET and perfusion changes in the tumour as measured by CT scan and tumour reduction in MRI). Akt levels will be measured in the first 60 patients (30 patient cohorts in each arm) both in the lymphocytes and in the tumour tissue.
Multi functional PET and MRI will be done in the first 30 patients of each arm to gain insight in changes in tumor SUV max and hypoxia following treatment with nelfinavir.
This trial represents a unique opportunity to test various hypotheses in the context of future translational research hence tumour biopsy samples will be stored in the clinical biology lab at ACTREC for future biomarker studies. To test various hypothesis we will require frozen tissues prior to and after treatment. In this case each patient will be her own control. Therefore during the time of the first biopsy we will keep some frozen material in liquid nitrogen.
Pharmacokinetic studies
Population pharmacokinetics of nelfinavir will be studied in the group of patients receiving Nelfinavir. For this, sparse sampling strategy will be followed. A random grouping table will be generated by the epidemiology and clinical trials unit and patient will be allotted to one of the groups for pharmacokinetic sampling. Patients will be allotted to one of the five groups sequentially. Four blood samples will be collected from each patient 7-10 days after the start of Nelfinavir. Timing of Blood sample would be based on the group in which the patient is. The sampling time points are so selected to cover the interval of drug administration. In addition one more blood sample will be collected before the last dose of administration of Cisplatin.
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
Pts on any drugs which has pharmacological interaction with nelfinavir:
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.
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.
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.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
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.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
If patient is randomized to nelfinavir arm then nelfinavir will be given orally with food at the dose of 1250 mg bid 5-7 days prior to start of chemoradiation. Then Pelvic EBRT (45-50 Gy/23-25 #/5weeks) + Weekly cisplatin 40mg/m2 \& ICRT 7Gy X4 # will be given.
Drug: Nelfinavir · Drug: Cisplatin · Radiation: Pelvic EBRT and Brachytherapy
If patient is randomized to standard arm (Cisplatin +Pelvic EBRT and Brachytherapy). In this patient will receive Pelvic EBRT (45-50 Gy/23-25 #/5weeks) + Weekly cisplatin 40mg/m2 \& ICRT 7Gy X4 #
Drug: Cisplatin · Radiation: Pelvic EBRT and Brachytherapy
Nelfinavir (HIV protease inhibitor) targets proteasome and inhibits AKT phosphorylation and plays an important role in radiosensitization of tumour cells.Nelfinavir will be given to the patient orally with food, because the bioavailability increases under the influence of food.
Cisplatin will be administered on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT. Patient will be premedicated with I.V Ondansetron to prevent emesis. Pre chemotherapy and post chemotherapy, patient will be administered IV fluids for effective renal clearance of cisplatin.
Pelvic EBRT will delivered by standard 4 field technique using 6MV/15 MV photon beams. Prior to delivery of radiation, patients will be simulated by CT simulator for planning the beam arrangements. Total dose of pelvic EBRT will be 45- 50Gy/23-25 #/5 weeks. The prescribed dose will be specified according to ICRU 50 guidelines. All patients will be treated with 3D conformal external radiation with target delineation and multileaf collimator leaf shaping.
Also known as: Radiation Therapy
Improvement in 3 year disease free survival
Improvement in 3 year disease free survival by the addition of Nelfinavir to patients with advanced carcinoma of cervix and receiving standard chemoradiation (Cisplatin and Radiotherapy).
Time frame: 3 years
Change in locoregional control rates at 3 years
Change in locoregional control rates at 3 years by the addition of Nelfinavir to patients with advanced carcinoma of cervix and receiving standard chemoradiation (Cisplatin and Radiotherapy).
Time frame: 3 years
Overall survival at 5 years
Overall survival at 5 years in test and control arms.
Time frame: 5 years
Incidence of grade 3/4 adverse events
Incidence of grade 3/4 adverse events in patients with advanced carcinoma of cervix and receiving Nelfinavir along with standard chemoradiation (Cisplatin and Radiotherapy)
Time frame: 5 years
Changes in Akt levels in the tumor
Changes in Akt levels in the tumor from pre Nelfinavir to post EBRT.
Time frame: 5 years
Change in tumour hypoxia using multifunctional PET/ MRI.
Change in tumour hypoxia using multifunctional PET/ MRI.
Time frame: 5 years
Interindividual variability of Volume of distribution
Cmax (Maximum concentration) will be estimated
Time frame: 5 years
Interindividual variability of Clearance of nelfinavir.
Clearence (litres per hour)
Time frame: 5 years
Interindividual variability of Clearence of Nelfinavir
Half Life (hrs)
Time frame: 5 years
Plan to share: No
Ran from Jan 2018 to primary completion in May 2024, 76 months.
Of 53 non-industry phase 3 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 107. This study's 76 months is close to that.
Counting every sponsor, half of 99 studies reached it within 55 months; a quarter within 24 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nelfinavir
Tata Memorial Hospital