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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University Hospital Heidelberg
Sponsor:
Collaborator:
German Cancer Research Center
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01566123
First received: March 20, 2012
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Local Control Rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: up to 5 years from first day of treatment ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to five years from first day of treatment ] [ Designated as safety issue: No ]
  • Acute toxicity [ Time Frame: up to 3 months from first day of treatment ] [ Designated as safety issue: No ]
    scored according to CTCAE 3.0

  • Late Toxicity [ Time Frame: up to 5 years after first day of treatment ] [ Designated as safety issue: No ]
    scored according to CTCAE 3.0 and RTOG criteria

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


Estimated Enrollment: 37
Study Start Date: March 2007
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
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
  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566123

Contacts
Contact: Juergen Debus, M.D., Ph.D. +496221568200 juergen.debus@med.uni-heidelberg.de

Locations
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Juergen Debus, M.D., Ph.D.    +49 6221 56 8200    juergen.debus@med.uni-heidelberg.de   
Contact: Falk FF Roeder, M.D.    +496221 56 8201    Falk.Roeder@med.uni-heidelberg.de   
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
Investigators
Principal Investigator: Juergen Debus, M.D., Ph.D. University Hospital Heidelberg
  More Information

No publications provided by University Hospital Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juergen Debus, Prof. Dr. Dr., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01566123     History of Changes
Other Study ID Numbers: RETROWTS
Study First Received: March 20, 2012
Last Updated: March 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Heidelberg:
retroperitoneal soft tissue sarcoma
IMRT
IORT

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

ClinicalTrials.gov processed this record on September 22, 2014