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Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma (STRASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344018
Recruitment Status : Unknown
Verified October 2016 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Recruiting
First Posted : April 28, 2011
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

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

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Abdominal recurrence-free survival

Secondary Outcome Measures :
  1. Acute toxicity profile of preoperative radiotherapy
  2. Perioperative complications
  3. Late complications
  4. Tumor response to preoperative radiotherapy
  5. Time to abdominal recurrence
  6. Metastasis-free survival
  7. Overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344018

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Contact: Anne Kirkpatrick +32 27741691

Show Show 38 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Sylvie Bonvalot Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Rick LM Haas, MD The Netherlands Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT01344018    
Other Study ID Numbers: EORTC-62092-22092
EORTC-62092 ( Other Identifier: EORTC )
EORTC-22092 ( Other Identifier: EORTC )
EU-21113 ( Other Identifier: EU )
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
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:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type