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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

March 20, 2012
March 28, 2012
March 2007
January 2020   (final data collection date for primary outcome measure)
Local Control Rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01566123 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retroperitoneal Soft Tissue Sarcoma
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
February 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Juergen Debus, M.D., Ph.D. +496221568200 juergen.debus@med.uni-heidelberg.de
Germany
 
NCT01566123
RETROWTS
Yes
Juergen Debus, University Hospital Heidelberg
University Hospital Heidelberg
German Cancer Research Center
Principal Investigator: Juergen Debus, M.D., Ph.D. University Hospital Heidelberg
University Hospital Heidelberg
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP