CompletedPhase 3

A Prospective Randomized Trial of Pre-Operative IMRT+Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma

United States150 participantsStarted 2003-05

Plain-language summary

This is a phase III clinical trial for patients with potentially completely resectable primary retroperitoneal sarcoma. Patients who take part will be divided into two groups, a radiation therapy plus surgery group and a surgery alone group. Patients in the radiation therapy plus surgery group will receive radiation treatments as an outpatient. Surgery to try to remove the remaining tumor will be done after the radiation treatments are completed. Patients in the surgery alone group will have surgery to try to remove all tumor.

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.

Inclusion Criteria: * Patients with primary retroperitoneal/pelvic soft tissue sarcoma. * Gross total resection (RO or R1) must be feasible. * No prior chemotherapy, immunotherapy or radiotherapy is allowable. * Patients should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with hospital policy. * Karnofsky performance status of \>= 70 % * No other concurrent chemotherapy, immunotherapy or radiotherapy is allowable. * Adequate organ function defined as follows: absolute granulocytes \>= 1,500/mm 3, platelets \>= 150,000/mm 3, serum bilirubin \<= 1.5 mg/dl, serum creatinine \<= 1.5 mg/dl. * Written informed consent (study specific) must be obtained from each patient prior to entering the study. * Patients should be willing to be followed at Memorial Sloan-Kettering Cancer Center during the course of treatment and follow-up. * Patients must be able to get IMRT radiotherapy at Memorial Sloan-Kettering Cancer Center Exclusion Criteria: * Patients presenting with primary non-retroperitoneal soft tissue sarcoma or recurrent retroperitoneal sarcoma. * Patients who are deemed unresectable by clinical/imaging criteria. * Patients with histologic diagnosis of gastrointestinal stromal sarcoma, desmoplastic small round cell tumor, desmoid, Ewing's sarcoma, PNET, adenosarcoma, granular cell tumor, mesothelioma or rhabdomyosarcoma are excluded from the study. * Patients with known metastatic …

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

To ascertain whether patients with completely resected (R0 + R1), primary retroperitoneal sarcoma who are randomized to pre-operative IMRT and surgery have a longer recurrence-free survival compared to patients randomized to treatment with surgery alone.

Trial details

NCT IDNCT00131898

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-09

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