NCT00942357|UnknownPhase 3ResultsDMC

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

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Gynecologic Oncology Group ClinicalTrials.gov

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6 other identifiers

GOG-0258NCI-2011-0195110-00685CDR0000649079U10CA180868U10CA027469

Study Type

interventional

Target

813

Locations

3 countries

Sites

670

Timeline

RegisteredJul 2009

StartedJun 2009

CompletionJul 2024

Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

813

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2009

Longer than P75 for phase_3

Geographic Reach

3 countries

670 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.1 years study duration

Study Start

First participant enrolled

June 29, 2009

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed

6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2016

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed

5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2024

Completed

Last Updated

October 19, 2021

Status Verified

September 1, 2021

Enrollment Period

6.6 years

First QC Date

July 17, 2009

Results QC Date

August 23, 2018

Last Update Submit

September 28, 2021

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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
Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment
Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0
Assessed every 6 months for 3 years
Overall Survival
From entry into the study to death or the date of last contact, assessed up to 8 years
Patient-reported Peripheral Neuropathy Symptoms
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 Quality of Life (QOL)
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

Study Arms (2)

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: CarboplatinDrug: CisplatinRadiation: Internal Radiation TherapyDrug: PaclitaxelOther: Quality-of-Life AssessmentRadiation: Radiation Therapy

Arm II (paclitaxel and carboplatin)

ACTIVE COMPARATOR

Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: CarboplatinDrug: PaclitaxelOther: Quality-of-Life Assessment

Interventions

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)Arm II (paclitaxel and carboplatin)

CisplatinDRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)

Internal Radiation TherapyRADIATION

Undergo brachytherapy

Also known as: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)

PaclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)Arm II (paclitaxel and carboplatin)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)Arm II (paclitaxel and carboplatin)

Radiation TherapyRADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma
Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional
Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
White blood cell (WBC) \>= 3,000/mcl
Absolute neutrophil count (ANC) \>= 1,500/mcl
Platelet count \>= 100,000/mcl
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x upper limit of normal (ULN)
Alkaline phosphatase =\< 2.5 times ULN
Bilirubin =\< 1.5 times ULN
Creatinine =\< institutional ULN
Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
Patients who have signed an approved informed consent and authorization permitting release of personal health information
+1 more criteria

You may not qualify if:

Patients with carcinosarcoma
Patients with recurrent endometrial cancer
Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension
Patients who have had pelvic or abdominal radiation therapy
Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
Patients with an estimated survival of less than three months
Patients with FIGO 2009 stage IVB endometrial cancer
Patients with parenchymal liver metastases
Patients who have received prior chemotherapy for endometrial cancer
Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Gynecologic Oncology Grouplead
National Cancer Institute (NCI)collaborator

Study Sites (670)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Tennessee Valley Gynecologic Oncology

Huntsville, Alabama, 35805, United States

Location

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

Location

Alaska Breast Care and Surgery LLC