Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma

NCT01344018 | Completed Results DMC

• 4 other identifiers: EORTC-62092-22092EORTC-62092EORTC-22092EU-21113
• Study Type: interventional
• Target: 266
• Locations: 13 countries
• Sites: 37

Brief 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.

Conditions

Sarcoma

Keywords

adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult malignant fibrous histiocytoma; adult malignant mesenchymoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Abdominal Recurrence or Death

  Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.

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

Secondary Outcomes (7)

• Acute Toxicity Profile of Preoperative Radiotherapy.

  From date of randomization to the date of surgical procedure, prior to surgery

• Perioperative Complications

  From the date of surgery, up to 60 days following surgery

• Late Complications

  From day 60 after surgery till end of follow-up, up to 7 years

• Tumor Response to Preoperative Radiotherapy

  Two weeks after completion of Pre-operative Radiotherapy, before Surgery

• Number of Patients With an Abdominal Recurrence

  ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years

Study Arms (2)

Surgery alone

ACTIVE COMPARATOR

En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.

Procedure: therapeutic conventional surgery

Preoperative radiotherapy followed by en-bloc surgery

EXPERIMENTAL

3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions

Procedure: therapeutic conventional surgery; Radiation: 3-dimensional conformal radiation therapy

Interventions

therapeutic conventional surgery PROCEDURE

Preoperative radiotherapy followed by en-bloc surgery; Surgery alone

3-dimensional conformal radiation therapy RADIATION

Preoperative radiotherapy followed by en-bloc surgery

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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) or MRI (with IV contrast) PATIENT CHARACTERISTICS: * WHO performance status 0-2 * WBC ≥ 2,500/mm\^3 * Platelet count ≥ 80,000/mm\^3 * Total bilirubin \< 1.5 times the upper limit normal * Calculated creatinine clearance normal * Functional contra-lateral kidney to the side involved by the RPS as assessed by intravenous pyelogram * Adequate cardiac function (NYHA class I-II) * ECG normal (without clinically significant abnormalities) * No history of any of the following disorders: * Bowel obstruction * Mesenteric ischemia * Severe chronic inflammatory bowel disease * Negative pregnancy test * Not pregnant or nursing concurrently and for at least 1 month after the surgery * Fertile patients must use effective contraception during the study treatment period and for at least 1 month after the surgery * No co-existing malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: * No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy * No prior abdominal or pelvic irradiation for another prior malignancy or other disease * No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted therapy) * No postoperative radiotherapy planned

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (37)

Dana-Farber Cancer Institute & Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)

Brussels, 1000, Belgium

Location

U.Z. Gasthuisberg

Leuven, 3000, Belgium

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

Montreal Quebec, Quebec, 1560, Canada

Location

University Copenhagen

Herlev, 2730, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitaetsklinikum

Cologne, 50937, Germany

Location

UniversitaetsMedizin Mannheim

Mannheim, Germany

Location

Klinikum der Universitaet

München, 81377, Germany

Location

Technische Universitaet Muenchen

München, Germany

Location

Centro Di Riferimento Oncologico

Aviano, 33081, Italy

Location

Istituto Clinico Humanitas

Milan, 20089, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Centre

Leiden, 2300, Netherlands

Location

Radboud University Medical Center

Nijmegen, 6500, Netherlands

Location

Radium Hospitalet

Oslo, 0310, Norway

Location

Maria Sklodowska-Curie Memorial Cancer Center

Warsaw, 02781, Poland

Location

Hospital General Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Karolinska University Hospital

Stockholm, 60500, Sweden

Location

Queen Elizabeth Medical Center

Birmingham, B15 2TH, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

Bristol, United Kingdom

Location

General Western Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Beatson-Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital

Leeds, United Kingdom

Location

University College Hospital

London, NW1 2PG, United Kingdom

Location

Royal Marsden Hospital - Chelsea, London

London, United Kingdom

Location

Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust - City Hospital campus

Nottingham, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (1)

• Bonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.

  PMID: 32941794 DERIVED

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Histiocytoma, Malignant Fibrous; Malignant mesenchymal tumor

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Histiocytoma

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Limitations and Caveats

The trial is limited by the short follow-up. An update will be done in 5 years. The trial is not powered for a difference in survival.

Results Point of Contact

• Title: EORTC HEADQUARTERS
• Organization: EORTC (European Organisation for Research and Treatment of Cancer)

eortc@eortc.be

+32 2 774 16 11

Study Officials

• Sylvie Bonvalot

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• Rick LM Haas, MD

  The Netherlands Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Locations

ES (2); GB (11); DK (1); CA (2); NO (1); DE (4); SE (1); IT (4); BE (2); US (1); NL (4); FR (3); PL (1)