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

NCT01566123 | Completed Phase 1 DMC

• 1 other identifier: RETROWTS
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Retroperitoneal Soft Tissue Sarcoma

Keywords

retroperitoneal soft tissue sarcoma; IMRT; IORT

Outcome Measures

Primary Outcomes (1)

• Local Control Rate

  5 year

Secondary Outcomes (5)

• Progression free survival

  up to 5 years from first day of treatment

• Overall Survival

  up to five years from first day of treatment

• Acute toxicity

  up to 3 months from first day of treatment

• Late Toxicity

  up to 5 years after first day of treatment

• Severe acute gastrointestinal toxicity

  up to 3 months from first day of treatment

Study Arms (1)

A

EXPERIMENTAL

Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma

Radiation: Neoadjuvant intensity-modulated radiation therapy (IMRT); Radiation: intraoperative radiation therapy (IORT)

Interventions

Neoadjuvant intensity-modulated radiation therapy (IMRT) RADIATION

neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy

A

intraoperative radiation therapy (IORT) RADIATION

during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• German Cancer Research Center: collaborator

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (3)

• Seidensaal K, Dostal M, Kudak A, Jaekel C, Meixner E, Liermann J, Weykamp F, Hoegen P, Mechtersheimer G, Willis F, Schneider M, Debus J. Preoperative Dose-Escalated Intensity-Modulated Radiotherapy (IMRT) and Intraoperative Radiation Therapy (IORT) in Patients with Retroperitoneal Soft-Tissue Sarcoma: Final Results of a Clinical Phase I/II Trial. Cancers (Basel). 2023 May 13;15(10):2747. doi: 10.3390/cancers15102747.

  PMID: 37345084 DERIVED

• Roeder F, Ulrich A, Habl G, Uhl M, Saleh-Ebrahimi L, Huber PE, Schulz-Ertner D, Nikoghosyan AV, Alldinger I, Krempien R, Mechtersheimer G, Hensley FW, Debus J, Bischof M. 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: interim analysis. BMC Cancer. 2014 Aug 27;14:617. doi: 10.1186/1471-2407-14-617.

  PMID: 25163595 DERIVED

• Roeder F, Schulz-Ertner D, Nikoghosyan AV, Huber PE, Edler L, Habl G, Krempien R, Oertel S, Saleh-Ebrahimi L, Hensley FW, Buechler MW, Debus J, Koch M, Weitz J, Bischof M. A 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. BMC Cancer. 2012 Jul 12;12:287. doi: 10.1186/1471-2407-12-287.

  PMID: 22788989 DERIVED

Study Officials

• Juergen Debus, M.D., Ph.D.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2007
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

DE (1)