Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients W… (NCT00006011) | Clinical Trial Compass
CompletedPhase 3
Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
United States659 participantsStarted 2000-07
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Se…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.
Timeframe: study entry up to 5 years post treatment