TerminatedPhase 2

Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

Stopped: Due to slow accrual. Results from the PORTEC3 the study rendered the hypothesis no longer valid.

United States31 participantsStarted 2009-01-16

Plain-language summary

This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Giving radiation therapy with chemotherapy may kill more tumor cells.

Who can participate

Age range

18 Years

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-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria: * Surgical stage I disease with \< 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement; * Surgical stage I disease with \>= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3); * Any surgical stage II disease (II); * Any surgical stage III disease (IIIA, IIIB, IIIC); and * Any surgical stage IV disease with no residual macroscopic tumor * Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria * Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 * Written voluntary informed consent Exclusion Criteria: * Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal * Total serum bilirubin \> 1.5 mg/dl * History of chronic or active hepatitis * Serum creatinine \> 2.0 mg/dl * Platelets \< 100,000/mm\^3 * Absolute neutrophil count (ANC) \< 1500/mm\^3 * Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry) * Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) * Patient with any prior …

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

Progression-free Survival (PFS)

Timeframe: From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years

Trial details

NCT IDNCT01041027

SponsorAlbert Einstein College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-01

Results submitted2023-09-28

View on ClinicalTrials.gov More Endometrial Adenocarcinoma trials