CompletedPhase 2

Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery

United States, Canada106 participantsStarted 2006-03

Plain-language summary

RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.

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.

DISEASE CHARACTERISTICS: * Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry * Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy * Histologically confirmed diagnosis of 1 of the following: * Endometrial cancer meeting 1 of the following criteria: * Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy * Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease * Stage IIIC with all of the following: * Pelvic lymph node positive only * Para-aortic nodes sampled negative * Not receiving chemotherapy * Cervical cancer meeting 1 of the following criteria: * Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following: * Positive pelvic nodes (negative para-aortic nodes) * Microscopic parametrial involvement and negative margins * Disease qualified by Sedlis criteria must have 2 of the following risk factors: * 1/3 or more stromal invasion * Lymph-vascular space invasion * Large clinical tumor diameter (≥ 4 cm) * Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan * No requirement for extended-field radiotherapy beyond the pelvis * No histologically confirmed papillary serous, clear cell, or n…

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

Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)

Timeframe: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.

Trial details

NCT IDNCT00331760

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2013-04-12

View on ClinicalTrials.gov More Cervical Cancer trials