CompletedPhase 3

Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis

United States, Canada370 participantsStarted 2004-08

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy. PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.

Who can participate

Age range

18 Years

Sex

ALL

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: * Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa) * The following histologies are eligible: * Alveolar soft part sarcoma * Anaplastic sarcoma * Angiosarcoma * Atypical lipomatous tumor (low-grade liposarcoma) * Clear cell sarcoma * Epithelioid sarcoma * Fibrosarcoma * Leiomyosarcoma * Liposarcoma (all subtypes) * Malignant fibrous histiocytoma * Malignant peripheral nerve sheath tumor * Myxofibrosarcoma * Neurofibrosarcoma * Spindle cell sarcoma * Synovial sarcoma * Unclassified sarcoma * The following histologies are not eligible: * Rhabdomyosarcoma * Extraosseous Ewing's sarcoma * Primitive neuroectodermal tumor * Osteosarcoma * Chondrosarcoma * Aggressive fibromatosis (desmoid tumor) * Gastrointestinal stromal tumor * Sarcomatoid carcinoma * Hemangiopericytoma * Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that ≥ 90% of the tumor volume is located within the retroperitoneal space * No bowel obstruction OR history of previous bowel obstruction attributed to retroperitoneal tumor * Primary non-visceral retroperitoneal masses consistent with sarcoma allowed provided diagnoses of carcinoma, melanoma, and lymphoma are excluded by immunohistochemistry * Measurable gross disease by …

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 at 5 years

Timeframe: at 5 years

Trial details

NCT IDNCT00091351

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-02

View on ClinicalTrials.gov More Sarcoma trials