Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
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
6 other identifiers
interventional
659
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedFirst Submitted
Initial submission to the registry
July 5, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedResults Posted
Study results publicly available
June 26, 2014
CompletedMay 19, 2015
April 1, 2015
9.7 years
July 5, 2000
May 20, 2014
April 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
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
Study Arms (2)
Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim)
EXPERIMENTALPatients 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.
Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Given SC
Given SC
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- Eastern Cooperative Oncology Groupcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela M. Kuras, Associate Director of Data Management
- Organization
- NRG Oncology Statistics and Data Management Center - Buffalo
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Homesley
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2000
First Posted
January 27, 2003
Study Start
July 1, 2000
Primary Completion
March 1, 2010
Last Updated
May 19, 2015
Results First Posted
June 26, 2014
Record last verified: 2015-04