A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with retroperitoneal sarcoma (RPS)

Phase 3

Completed

• Conditions: retroperitoneal sarcoma; sarcoma; 10072990; 10041297

• Registration Number: NL-OMON41672
• Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

*18 years old
WHO performance status * 2 (see Appendix C)
Primary untreated soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
Unifocal tumor
Histologically-proven RPS, see also exclusion criteria
Tumor both operable and suitable for radiotherapy (anticipated macroscopically complete resection, R0/R1 resection)
Patients must have American Society of Anesthesiologist (ASA) score * 2 (see Appendix G)
Normal renal function: Calculated creatinine clearance within normal value (calculated by Cockcroft-Gault; see Appendix E)
Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram (done during the baseline CT-scan) or differential renal isotope scan
Normal bone marrow and hepatic function:
* White Blood cells * 2.5 x10 9 cells/L
* Platelets * 80 x10 9 cells/L
* Total bilirubin < 1.5 time the institutional upper limit normal of value (ULN)
Adequate cardiac function: less or equal to NYHA II (see Appendix D)
Normal 12 lead ECG (without clinically significant abnormalities)
Written informed consent

Exclusion Criteria

Sarcoma originating from bone structure, abdominal or gynecological viscera
Multifocal disease or metastatic disease
Extension through the sciatic notch or across the diaphragm
The following diagnoses are excluded:
* Gastro-intestinal stromal tumor (GIST)
* Rhabdomyosarcomas
* PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma,
* aggressive fibromatosis
* sarcomatoid or metastatic carcinoma
Expected R2 resection
History of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
Pregnancy or breast feeding state (Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and for at least 1 month after the surgery)
Co-existing malignancy within the last 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
Prior abdominal or pelvic irradiation for other prior malignancy or other disease
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>abdominal recurrence free survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>safety secondary endpoints:<br /><br>- acute toxicity profile of preoperative radiotherapy<br /><br>- perioperative complications<br /><br>- late complications<br /><br>efficacy secondary endpoints:<br /><br>- tumor response<br /><br>- time to abdominal recurrence<br /><br>- metastasis-free survival<br /><br>- overall survival</p><br>