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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant intensity-modulated radiation therapy (IMRT) | Radiation | neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juergen Debus, M.D., Ph.D. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37345084 | Derived | 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. | |
| 25163595 |
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| intraoperative radiation therapy (IORT) | Radiation | during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease |
|
scored according to CTCAE 3.0 |
| up to 3 months from first day of treatment |
| Late Toxicity | scored according to CTCAE 3.0 and RTOG criteria | up to 5 years after first day of treatment |
| 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 |
| 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. |
| 22788989 | 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. |