Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01566123
Recruitment Status : Recruiting
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
German Cancer Research Center
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Brief Summary:

Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. In contrast to extremity sarcoma, postoperative radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some centers to overcome these dose limitations and resulted in improved outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. As postoperative administration of RT has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT) are considered.

Therefore the RETROWTS trials has been designed as a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy) followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS. The primary objective is the local control rate after five years. Secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.

Condition or disease Intervention/treatment Phase
Retroperitoneal Soft Tissue Sarcoma Radiation: Neoadjuvant intensity-modulated radiation therapy (IMRT) Radiation: intraoperative radiation therapy (IORT) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Phase I/II Trial to Investigate Preoperative Dose-Escalated Intensity-Modulated Radiation Therapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients With Retroperitoneal Soft Tissue Sarcoma
Study Start Date : March 2007
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Radiation: Neoadjuvant intensity-modulated radiation therapy (IMRT)
    neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy
    Radiation: intraoperative radiation therapy (IORT)
    during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease

Primary Outcome Measures :
  1. Local Control Rate [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 5 years from first day of treatment ]
  2. Overall Survival [ Time Frame: up to five years from first day of treatment ]
  3. Acute toxicity [ Time Frame: up to 3 months from first day of treatment ]
    scored according to CTCAE 3.0

  4. Late Toxicity [ Time Frame: up to 5 years after first day of treatment ]
    scored according to CTCAE 3.0 and RTOG criteria

  5. Severe acute gastrointestinal toxicity [ Time Frame: up to 3 months from first day of treatment ]
    severe defined as grade >= III, scored according to CTC AE 3.0

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • written informed consent
  • histologically confirmed, primary or locally recurrent soft tissue sarcoma of the retroperitoneal space
  • judged as at least marginally resectable
  • absence of distant metastases
  • tumor size ≥ 5 cm

Exclusion Criteria:

  • missing written informed consent
  • missing histological confirmation of soft tissue sarcoma
  • Desmoid tumor (syn. aggressive fibromatosis)
  • judged as gross incomplete or not resectable
  • incomplete staging
  • presence of distant metastases
  • prior radiation therapy to the abdominal region
  • participation in another clinical interventional study
  • inflammatory bowel disease

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): NCT01566123

Contact: Juergen Debus, M.D., Ph.D. +496221568200

University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Juergen Debus, M.D., Ph.D.    +49 6221 56 8200   
Contact: Falk FF Roeder, M.D.    +496221 56 8201   
Principal Investigator: Juergen Debus, M.D., Ph         
Sub-Investigator: Marc Bischof, M.D.         
Sub-Investigator: Falk FF Roeder, M.D.         
Sub-Investigator: Juergen Weitz, M.D.         
Sub-Investigator: Moritz Koch, M.D.         
Sub-Investigator: Susanne Oertel, M.D.         
Sponsors and Collaborators
University Hospital Heidelberg
German Cancer Research Center
Principal Investigator: Juergen Debus, M.D., Ph.D. University Hospital Heidelberg

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Juergen Debus, Prof. Dr. Dr., University Hospital Heidelberg Identifier: NCT01566123     History of Changes
Other Study ID Numbers: RETROWTS
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by Juergen Debus, University Hospital Heidelberg:
retroperitoneal soft tissue sarcoma

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