A Phase 3 interventional study of Carboplatin and Ifosfamide in Mixed Mesodermal (Mullerian) Tumor, Ovarian Carcinosarcoma and Recurrent Fallopian Tube Carcinoma, sponsored by GOG Foundation. Status unknown at 538 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by GOG Foundation · Phase 3, Interventional, and Treatment
This randomized phase III trial studies paclitaxel and carboplatin see how well they work compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.
PRIMARY OBJECTIVES:
I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy.
SECONDARY OBJECTIVES:
I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior progression-free survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy.
II. To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin chemotherapy is reduced compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.
III. To determine if treatment with combination paclitaxel and carboplatin chemotherapy is associated with superior patient-reported quality of life and neurotoxicity scores compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.
TERTIARY OBJECTIVES:
I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and deoxyribonucleic acid (DNA) extracted from whole blood for future research.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.
ARM II: Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.
In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
60 studies on the registry are indexed under Carcinosarcoma; 12 are open to participants now.
This study's enrollment of 637 is above the median of 48 across 52 interventional studies indexed under Carcinosarcoma.
Browse Carcinosarcoma studies →GOG Foundation is the lead sponsor of 18 studies on the registry; 4 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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.
Drug: Carboplatin · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.
Drug: Ifosfamide · Drug: Paclitaxel · Other: Quality-of-Life Assessment
Given IV
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Given IV
Also known as: Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942
Given IV
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Ancillary studies
Also known as: Quality of Life Assessment
Overall Survival
Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 115 months.
Duration of Progression-free Survival
Measured in months from randomization to last contact or the earlier of the date of progression or death.
Time frame: Approximately 9 years and 7 months
Incidence of Adverse Events as Assessed by CTCAE Version 3.0
Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
Time frame: Patients were assessed for adverse events during active protocol treatment and up to 30 days after the last cycle of treatment on the protocol.
Patient-Reported Quality of Life (QOL) - Baseline
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Baseline - Prior to study treatment
Patient Reported Quality of Life (QOL) - Post Baseline
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1.
Patient Reported Peripheral Neuropathy Symptoms - Baseline
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Baseline (Pre cycle 1)
Patient-reported Peripheral Neuropathy Symptoms - Post Baseline
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
Time frame: Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1
A total of 637 subjects were enrolled between 08/17/2009 and 3/24/14. Enrollment initially included uterine carcinosarcoma and was expanded to ovarian carcinosarcoma in June 2010 and then to include fallopian tube and peritoneal carcinosarcoma in October 2013. The primary analysis was restricted to patients with uterine carcinosarcoma.
| Milestone | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects | Regimen IV - Non-uterine Carcinsarcoma Subjects |
|---|---|---|---|---|
| Started | 268 | 268 | 51 | 50 |
| Completed | 142 | 145 | 27 | 25 |
| Not completed | 126 | 123 | 24 | 25 |
| Withdrew: Adverse event | 28 | 23 | 4 | 9 |
| Withdrew: Death | 4 | 2 | 0 | 0 |
| Withdrew: Lack of efficacy | 32 | 22 | 8 | 6 |
| Withdrew: Withdrawal by subject | 14 | 10 | 4 | 3 |
| Withdrew: Medical reason | 4 | 2 | 1 | 0 |
| Withdrew: Ineligible | 40 | 47 | 7 | 4 |
| Withdrew: Never treated | 4 | 17 | 0 | 3 |
Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.
| months | Regimen I- Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects |
|---|---|---|
| Overall Survival | 37.3 (25.7 to 49.0) | 29 (21.9 to 43.1) |
Measured in months from randomization to last contact or the earlier of the date of progression or death.
| months | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects | Regimen IV - Non-uterine Carcinsarcoma Subjects |
|---|---|---|---|---|
| Duration of Progression-free Survival | 16.3 (13.0 to 18.9) | 11.7 (10.1 to 17.3) | 14.6 (8.1 to 16.4) | 10.3 (8.5 to 19.0) |
Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.
| Participants | Regimen I - Uterine and Non-Uterine Subjects | Regimen II - All Uterine and Non-Uterine Subjects |
|---|---|---|
| Grade 1 | 3 | 3 |
| Grade 2 | 22 | 80 |
| Grade 3 | 107 | 97 |
| Grade 4 | 130 | 61 |
| Grade 5 | 6 | 3 |
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
| units on a scale (time point) | Regimen I - Uterine and Non-Uterine Subjects | Regimen II - Uterine and Non-Uterine Subjects |
|---|---|---|
| Patient-Reported Quality of Life (QOL) - Baseline | 96.2 ± 1.1 | 97.5 ± 1.2 |
Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
| units on a scale (time point) | Regimen I - Uterine and Non-Uterine Subjects | Regimen II - Uterine and Non-Uterine Subjects |
|---|---|---|
| Pre-cycle 3 | 93.3 ± 0.9 | 93.3 ± 1.0 |
| Pree-cycle 6 | 91.6 ± 1.1 | 91.6 ± 1.1 |
| 30 weeks post cycle 1 | 98.0 ± 1.1 | 97.6 ± 1.3 |
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
| units on a scale-baseline | Regimen I - Uterine and Non-Uterine Subjects | Regimen II - Uterine and Non-Uterine Subjects |
|---|---|---|
| Patient Reported Peripheral Neuropathy Symptoms - Baseline | 40.2 ± 0.3 | 41.0 ± 0.3 |
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
| units on a scale | Regimen I - Uterine and Non-Uterine Subjects | Regimen II - Uterine and Non-Uterine Subjects |
|---|---|---|
| Prior to cycle 3 | 37.2 ± 0.4 | 37.0 ± 0.5 |
| Prior to cycle 6 | 34.1 ± 0.6 | 34.2 ± 0.6 |
| 30 weeks post cycle 1 | 34.8 ± 0.6 | 34.9 ± 0.6 |
Collected over Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regimen I - Uterine and Non-uterine Carcinosarcoma | 160/272 (58.8%) | 80/268 (29.9%) | 268/268 (100%) |
| Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects | 160/267 (59.9%) | 68/247 (27.5%) | 244/247 (98.8%) |
| Event | Regimen I - Uterine and Non-uterine Carcinosarcoma | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects |
|---|---|---|
| NeutrophilsBlood and lymphatic system disorders | 32/268 | 12/247 |
| DehydrationGastrointestinal disorders | 6/268 | 3/247 |
| ConfusionNervous system disorders | 0/268 | 5/247 |
| Thrombosis/Thrombus/EmbolismVascular disorders | 2/268 | 4/247 |
| Pain: Chest /Thorax NosGeneral disorders | 0/268 | 3/247 |
| Renal FailureRenal and urinary disorders | 1/268 | 3/247 |
| NauseaGastrointestinal disorders | 3/268 | 0/247 |
| Febrile NeutropeniaInfections and infestations | 3/268 | 2/247 |
| Pain: Abdominal Pain NosGeneral disorders | 3/268 | 0/247 |
| HemoglobinBlood and lymphatic system disorders | 1/268 | 2/247 |
| Event | Regimen I - Uterine and Non-uterine Carcinosarcoma | Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects |
|---|---|---|
| HemoglobinBlood and lymphatic system disorders | 249/268 | 232/247 |
| NeutrophilsBlood and lymphatic system disorders | 245/268 | 116/247 |
| LeukocytesBlood and lymphatic system disorders | 239/268 | 164/247 |
| FatigueGeneral disorders | 192/268 | 177/247 |
| Hair Loss/Alopecia (Scalp Or Body)Skin and subcutaneous tissue disorders | 190/268 | 171/247 |
| PlateletsBlood and lymphatic system disorders | 178/268 | 137/247 |
| Neuropathy-SensoryNervous system disorders | 178/268 | 158/247 |
| NauseaGastrointestinal disorders | 132/268 | 131/247 |
| ConstipationGastrointestinal disorders | 129/268 | 119/247 |
| DiarrheaGastrointestinal disorders | 77/268 | 55/247 |
Eligible patients
| Age, Customized(Participants) | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects | Regimen IV - Non-uterine Carcinsarcoma Subjects | Total |
|---|---|---|---|---|---|
| 20-29 years | 0 | 3 | 0 | 0 | 3 |
| 30-39 years | 1 | 1 | 2 | 0 | 4 |
| 40-49 years | 12 | 8 | 3 | 2 | 25 |
| 50-59 years | 46 | 45 | 12 | 18 | 121 |
| 60-69 years | 111 | 111 | 15 | 15 | 252 |
| 70-89 years | 58 | 53 | 12 | 11 | 134 |
| Sex: Female, Male(Participants) | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects | Regimen IV - Non-uterine Carcinsarcoma Subjects | Total |
|---|---|---|---|---|---|
| Female | 228 | 221 | 44 | 46 | 539 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects | Regimen IV - Non-uterine Carcinsarcoma Subjects | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 8 | 2 | 3 | 17 |
| Not Hispanic or Latino | 215 | 206 | 42 | 40 | 503 |
| Unknown or Not Reported | 9 | 7 | 0 | 3 | 19 |
| Race (NIH/OMB)(Participants) | Regimen I - Uterine Carcinsarcoma Subjects | Regimen II - Uterine Carcinsarcoma Subjects | Regimen III - Non-uterine Carcinsarcoma Subjects | Regimen IV - Non-uterine Carcinsarcoma Subjects | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 0 | 3 |
| Asian | 9 | 9 | 2 | 4 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 66 | 72 | 4 | 4 | 146 |
| White | 150 | 133 | 37 | 36 | 356 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 6 | 1 | 2 | 10 |
Showing the first 100 of 538 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2009 to primary completion in Mar 2019, 115 months.
Results were first posted in Aug 2020, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carboplatin · Ifosfamide
GOG Foundation