Who is sponsoring NCT00942357?

NCT00942357 is sponsored by Gynecologic Oncology Group.

What drugs are being tested in NCT00942357?

Interventions in NCT00942357: Carboplatin, Cisplatin, Internal Radiation Therapy, Paclitaxel, Quality-of-Life Assessment, Radiation Therapy.

What condition does NCT00942357 study?

NCT00942357 studies Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7.

Is NCT00942357 still recruiting?

NCT00942357 is currently status unknown. Last updated 19 October 2021.

Are results published for NCT00942357?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-10-19 · How we verify

NCT00942357

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

Status unknown Phase 3 Results posted Last updated 19 October 2021

What this trial tests

Phase 3 trial testing Carboplatin in Endometrial Clear Cell Adenocarcinoma in 813 participants. Status unknown.

Timeline

29 June 2009

Primary endpoint
15 February 2016

28 July 2024

Quick facts

Lead sponsor	Gynecologic Oncology Group
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	813
Start date	29 June 2009
Primary completion	15 February 2016
Estimated completion	28 July 2024
Sites	670 locations across Canada, United States, South Korea

Drugs / interventions tested

Carboplatin (Carboplatin) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Internal Radiation Therapy
Paclitaxel — full drug profile →
Quality-of-Life Assessment
Radiation Therapy

Conditions studied

Endometrial Clear Cell Adenocarcinoma — all drugs for Endometrial Clear Cell Adenocarcinoma →
Endometrial Serous Adenocarcinoma — all drugs for Endometrial Serous Adenocarcinoma →
Stage IA Uterine Corpus Cancer AJCC v7 — all drugs for Stage IA Uterine Corpus Cancer AJCC v7 →
Stage IB Uterine Corpus Cancer AJCC v7 — all drugs for Stage IB Uterine Corpus Cancer AJCC v7 →

Sponsor

Gynecologic Oncology Group — full company profile →

Who can join

18 and older, female only, with Endometrial Clear Cell Adenocarcinoma or Endometrial Serous Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Recurrence, Progression or Death Primary · Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.

Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	132
Arm II (Paclitaxel and Carboplatin)	139

Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 Secondary · Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment

The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.

Grade 1

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	5
Arm II (Paclitaxel and Carboplatin)	15

Grade 2

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	139
Arm II (Paclitaxel and Carboplatin)	118

Grade 3

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	154
Arm II (Paclitaxel and Carboplatin)	119

Grade 4

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	48
Arm II (Paclitaxel and Carboplatin)	105

Grade 5

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	0
Arm II (Paclitaxel and Carboplatin)	3

Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0 Secondary · Assessed every 6 months for 3 years

The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.

Grade 1

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	85
Arm II (Paclitaxel and Carboplatin)	96

Grade 2

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	71
Arm II (Paclitaxel and Carboplatin)	79

Grade 3

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	45
Arm II (Paclitaxel and Carboplatin)	33

Grade 4

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	14
Arm II (Paclitaxel and Carboplatin)	7

Grade 5

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	1
Arm II (Paclitaxel and Carboplatin)	4

Patient-reported Peripheral Neuropathy Symptoms Secondary · Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment

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 4 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). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When una

Baseline

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	14.9	± 0.1
Arm II (Paclitaxel and Carboplatin)	15.0	± 0.1

6 weeks

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	14.4	± 0.4
Arm II (Paclitaxel and Carboplatin)	12.4	± 0.4

18 weeks

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	10.4	± 0.4
Arm II (Paclitaxel and Carboplatin)	9.9	± 0.5

70 weeks

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	11.8	± 0.4
Arm II (Paclitaxel and Carboplatin)	11.6	± 0.4

Patient-reported Quality of Life (QOL) Secondary · Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment

Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 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). According to the FACIT measurement system, a subscale score was the summation of the individual item scores i

Baseline

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	98.4	± 0.8
Arm II (Paclitaxel and Carboplatin)	97.6	± 0.8

6 weeks

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	89.5	± 2.1
Arm II (Paclitaxel and Carboplatin)	90.9	± 2.0

18 weeks

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	87.8	± 2.1
Arm II (Paclitaxel and Carboplatin)	93.0	± 2.0

70 weeks

Group	Value	95% CI
Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)	96.0	± 2.2
Arm II (Paclitaxel and Carboplatin)	99.4	± 2.1

Adverse events — posted to ClinicalTrials.gov

Time frame: All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)

Serious: 78/346 (23%)

Deaths: 0

Arm II (Paclitaxel and Carboplatin)

Serious: 61/361 (17%)

Deaths: 0

Serious adverse events (63 terms)

Reaction	System	Arm I (Cisplatin, Radiatio…	Arm II (Paclitaxel and Car…
Neutrophils	Blood and lymphatic system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Thrombosis/Thrombus/Embolism	Vascular disorders	—	—
Hemoglobin	Blood and lymphatic system disorders	—	—
Allergic Reaction/Hypersensitivity	Immune system disorders	—	—
Obstruction, Gi - Small Bowel Nos	Gastrointestinal disorders	—	—
Infection - Other	Infections and infestations	—	—
Renal Failure	Renal and urinary disorders	—	—
Platelets	Blood and lymphatic system disorders	—	—
S/N Arrhythmia: Atrial Fibrillation	Cardiac disorders	—	—
Fever	General disorders	—	—
Dehydration	Gastrointestinal disorders	—	—
Inf W/Nml Or Gr 1 Or 2 Anc: Blood	Infections and infestations	—	—
Febrile Neutropenia	Infections and infestations	—	—
Inf Unknown Anc: Blood	Infections and infestations	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Muscle Weakness - Extremity-Lower	Musculoskeletal and connective tissue disorders	—	—
Syncope	Nervous system disorders	—	—
Pain: Back	General disorders	—	—
Pain: Abdominal Pain Nos	General disorders	—	—
Auditory/Ear - Other	Ear and labyrinth disorders	—	—
Blood/Bone Marrow - Other	Blood and lymphatic system disorders	—	—
S/N Arrhythmia: Sinus Tachycardia	Cardiac disorders	—	—

Other adverse events (325 terms — click to expand)

Reaction	System	Arm I (Cisplatin, Radiatio…	Arm II (Paclitaxel and Car…
Hemoglobin	Blood and lymphatic system disorders	—	—
Fatigue	General disorders	—	—
Leukocytes	Blood and lymphatic system disorders	—	—
Hair Loss/Alopecia (Scalp Or Body)	Skin and subcutaneous tissue disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Neuropathy-Sensory	Nervous system disorders	—	—
Neutrophils	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Platelets	Blood and lymphatic system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Anorexia	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Pain: Joint	General disorders	—	—
Pain: Muscle	General disorders	—	—
Pain: Abdominal Pain Nos	General disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—
Pain: Bone	General disorders	—	—
Insomnia	General disorders	—	—
Pain: Extremity-Limb	General disorders	—	—
Urinary Frequency	Renal and urinary disorders	—	—
Dizziness	Nervous system disorders	—	—
Edema: Limb	Blood and lymphatic system disorders	—	—
Pain: Head/Headache	General disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Hypertension	Cardiac disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Weight Loss	General disorders	—	—
Mood Alteration - Anxiety	Nervous system disorders	—	—
Alkaline Phosphatase	Metabolism and nutrition disorders	—	—
Creatinine	Metabolism and nutrition disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Hot Flashes	Endocrine disorders	—	—
Taste Alteration	Gastrointestinal disorders	—	—
Mood Alteration - Depression	Nervous system disorders	—	—
Muscle Weakness - Whole Body/Generalized	Musculoskeletal and connective tissue disorders	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Neutrophils, Diarrhea, Lymphopenia, Thrombosis/Thrombus/Embolism, Hemoglobin, Allergic Reaction/Hypersensitivity, Obstruction, Gi - Small Bowel Nos, Infection - Other.

Data from ClinicalTrials.gov NCT00942357 adverse events section.

Sponsor's own description

This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer.
Matei D, Filiaci V, Randall ME, Mutch D, et al · · 2019 · cited 334× · PMID 31189035 · DOI 10.1056/nejmoa1813181
Recent Advances in Endometrial Cancer.
Tran AQ, Gehrig P. · · 2017 · cited 42× · PMID 28184290 · DOI 10.12688/f1000research.10020.1
Determinants of Sensitivity to Radiotherapy in Endometrial Cancer.
Sorolla MA, Parisi E, Sorolla A. · · 2020 · cited 22× · PMID 32679719 · DOI 10.3390/cancers12071906
Molecular classification of endometrial cancers (EC) and association with relapse-free survival (RFS) and overall survival (OS) outcomes: Ancillary analysis of GOG-0258.
Clements A, Enserro D, Strickland KC, Previs R, et al · · 2025 · cited 15× · PMID 39854806 · DOI 10.1016/j.ygyno.2025.01.006
Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma.
Matei DE, Enserro DM, Randall ME, Mutch D, et al · · 2025 · cited 7× · PMID 39700442 · DOI 10.1200/jco.24.01121
Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study.
Matulonis UA, Huang HQ, Filiaci VL, Randall M, et al · · 2022 · cited 6× · PMID 34903380 · DOI 10.1016/j.ygyno.2021.11.021
Highlights from the Gynecologic Oncology Track at the 2017 Annual Meeting of the American Society of Clinical Oncology.
Wolford JE, Tewari KS. · · 2017 · cited 3× · PMID 28758380 · DOI 10.3802/jgo.2017.28.e74

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

NCT04832438 — 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma · Phase 2 · withdrawn
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting

Other recruiting trials for Endometrial Clear Cell Adenocarcinoma

Currently open trials in the same condition.

NCT05256225 — Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carci · Phase 3 · recruiting
NCT05112601 — Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma · Phase 2 · recruiting
NCT03914612 — Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carbopl · Phase 3 · active not recruiting
NCT05049538 — Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancers · recruiting
NCT03422198 — Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer · Phase 3 · recruiting

Other Gynecologic Oncology Group trials

Trials by the same sponsor.

NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer · Phase 2 · active not recruiting
NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer · Phase 2 · active not recruiting
NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent · Phase 2, PHASE3 · unknown
NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Phase 2 · completed
NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00942357 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gynecologic Oncology Group
Last refreshed: 19 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00942357.

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