Clinical trial NCT01566123: Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Retroperitoneal Soft Tissue Sarcoma
Keywords: retroperitoneal soft tissue sarcoma
IMRT
IORT
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2012-03-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Local Control Rate
timeFrame: 5 year
Secondary outcomes:
measure: Progression free survival
timeFrame: up to 5 years from first day of treatment
measure: Overall Survival
timeFrame: up to five years from first day of treatment
measure: Acute toxicity
timeFrame: up to 3 months from first day of treatment
measure: Late Toxicity
timeFrame: up to 5 years after first day of treatment
measure: Severe acute gastrointestinal toxicity
timeFrame: up to 3 months from first day of treatment
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Juergen Debus, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.