Retroperitoneal Soft Tissue Sarcoma Clinical Trial
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
| Verified date | April 2020 |
| Source | University Hospital Heidelberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | February 2020 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Heidelberg | Heidelberg | Baden-Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Heidelberg | German Cancer Research Center |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Local Control Rate | 5 year | ||
| Secondary | Progression free survival | up to 5 years from first day of treatment | ||
| Secondary | Overall Survival | up to five years from first day of treatment | ||
| Secondary | Acute toxicity | scored according to CTCAE 3.0 | up to 3 months from first day of treatment | |
| Secondary | Late Toxicity | scored according to CTCAE 3.0 and RTOG criteria | up to 5 years after first day of treatment | |
| Secondary | Severe acute gastrointestinal toxicity | severe defined as grade >= III, scored according to CTC AE 3.0 | up to 3 months from first day of treatment |