Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

April 30, 2015 updated by: Gynecologic Oncology Group

A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma

Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel.

II. Compare short and long-term toxic effects of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field). Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery. Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.

Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or pegfilgrastim on days 2-11.

Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Gynecologic Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed advanced endometrial carcinoma with any histology, including:

    • Clear cell and serous papillary carcinoma

  • Surgical stage III disease, including:

    • Positive adnexa
    • Tumor invading the serosa
    • Positive pelvic and/or paraaortic nodes
    • Involvement of bowel mucosa
    • Intraabdominal metastases
    • Positive pelvic washings
    • Vaginal involvement within the radiation port

  • Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy

    • Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm

    • Paraaortic lymph node sampling allowed

      • If positive, must have negative chest CT scan
  • No recurrent disease
  • No parenchymal liver metastases
  • No disease outside the abdomen
  • Performance status - GOG 0-2
  • At least 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT/SGPT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • Creatinine no greater than 1.6 mg/dL
  • LVEF at least 50% within 6 months of study entry
  • No other prior or concurrent malignancy within the past 5 years except adequately treated nonmelanoma skin cancer
  • No serious comorbid illness that would preclude study participation
  • No prior chemotherapy
  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for prior malignancy
  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim)
Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) SC or pegfilgrastim on days 2-11.
Drug: Cisplatin
Given IV
Drug: Doxorubicin Hydrochloride
Given IV
Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • Neulasta
  • GCSF-SD01
Biological: Filgrastim
Given SC
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Nivestim
Experimental: Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim)
Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Cisplatin
Given IV
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX
Drug: Doxorubicin Hydrochloride
Given IV
Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • Neulasta
  • GCSF-SD01
Biological: Filgrastim
Given SC
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Nivestim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
Time Frame: study entry up to 5 years post treatment

Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.

Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.

Intention to treat among eligible participants who receive random treatment allocation.
study entry up to 5 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Investigators

  • Principal Investigator: Howard Homesley, Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0184 (Other Identifier: CTEP)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2012-02350 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • ECOG-G0184
  • RTOG-EN0130
  • CDR0000068020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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