CompletedNot Applicable

Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma

United States, Belgium, Canada266 participantsStarted 2012-01

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist, imaging-guided or surgical biopsy, including the following: * Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis * Sarcoma not originated from bone structure, abdominal, or gynecological viscera * Unifocal tumor (not multifocal disease) * Absence of extension through the sciatic notch or across the diaphragm * The following histological sub-types are not allowed: * Gastrointestinal stromal tumor (GIST) * Rhabdomyosarcomas * Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma * Osteosarcoma or chondrosarcoma * Aggressive fibromatosis * Sarcomatoid or metastatic carcinoma * No metastatic disease * Untreated disease * Tumor must be operable and suitable for radiotherapy, based on the following criteria: * Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon, radiation oncologist, and radiologist (anticipated macroscopically complete resection, R0/R1 resection) * No surgery anticipated to be R2 on the CT scan before randomization * Must have American Society of Anesthesiologist (ASA) score ≤ 2 * None of the following unresectable criteria: * Involvement of superior mesenteric artery * Involvement of aorta * Involvement of bone * Must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT (with IV and PO contrast)…

What they're measuring

Number of Patients With Abdominal Recurrence or Death

Timeframe: ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.

Trial details

NCT IDNCT01344018

SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2019-03

Results submitted2021-09-20