Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma (STRASS)

This study is currently recruiting participants.
Verified June 2013 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01344018
First received: April 27, 2011
Last updated: February 13, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Sarcoma
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Abdominal recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute toxicity profile of preoperative radiotherapy [ Designated as safety issue: Yes ]
  • Perioperative complications [ Designated as safety issue: Yes ]
  • Late complications [ Designated as safety issue: Yes ]
  • Tumor response to preoperative radiotherapy [ Designated as safety issue: No ]
  • Time to abdominal recurrence [ Designated as safety issue: No ]
  • Metastasis-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: January 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery alone
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
Experimental: Preoperative radiotherapy followed by en-bloc surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
Procedure: therapeutic conventional surgery Radiation: 3-dimensional conformal radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • To assess whether there is a difference in abdominal recurrence-free survival between retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery.

Secondary

  • To assess whether there is a difference in metastasis-free survival, abdominal recurrence-free interval, and overall survival between these patients.
  • To assess tumor response in patients undergoing preoperative radiotherapy.
  • To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to institution and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following randomization.
  • Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass within 4-8 weeks after the completion of RT.

Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during surgery to identify new prognostic factors for translational research.

After completion of study therapy, patients are followed at day 60 post-surgery and every 6 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344018

Contacts
Contact: Anne Kirkpatrick +32 27741691 anne.kirkpatrick@eortc.be

Locations
United States, Massachusetts
Dana-Farber Cancer Institute & Harvard Medical School Recruiting
Boston, Massachusetts, United States
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
France
Institut Bergonie Recruiting
Bordeaux, France
Centre Leon Berard Recruiting
Lyon, France
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Sylvie Bonvalot, Dr    0033/142114383    bonvalot@igr.fr   
Principal Investigator: Sylvie Bonvalot, Dr         
Germany
UniversitaetsMedizin Mannheim Recruiting
Mannheim, Germany
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy
Netherlands
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis Recruiting
Amsterdam, Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Leiden University Medical Centre Recruiting
Leiden, Netherlands
United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre Recruiting
Bristol, United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital Recruiting
Leeds, United Kingdom
Royal Marsden Hospital - Chelsea, London Recruiting
London, United Kingdom
Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital campus Recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Sylvie Bonvalot Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Rick LM Haas, MD The Netherlands Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01344018     History of Changes
Other Study ID Numbers: EORTC-62092-22092, EORTC-62092, EORTC-22092, EU-21113
Study First Received: April 27, 2011
Last Updated: February 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Denmark: Ethics Committee
United Kingdom: Research Ethics Committee
Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014