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.
BACKGROUND
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 the dose limitations and resulted in increased 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.


METHODS
The trial is 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.


CONCLUSIONS
The present study evaluates combined neoadjuvant dose-escalated IMRT followed by surgery and IORT concerning its value for improved local control without markedly increased toxicity.


BACKGROUND
NCT01566123.
Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany. F.Roeder@dkfz.de
Falk
F
Roeder
Daniela
D
Schulz-Ertner
Anna V
AV
Nikoghosyan
Peter E
PE
Huber
Lutz
L
Edler
Gregor
G
Habl
Robert
R
Krempien
Susanne
S
Oertel
Ladan
L
Saleh-Ebrahimi
Frank W
FW
Hensley
Markus W
MW
Buechler
Juergen
J
Debus
Moritz
M
Koch
Juergen
J
Weitz
Marc
M
Bischof
D017321:Clinical Trials, Phase I as Topic / Q000379:methods; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D006801:Humans; D007430:Intraoperative Care / Q000379:methods; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000379:methods; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods; D012186:Retroperitoneal Neoplasms / Q000532:radiotherapy* / Q000601:surgery*; D012509:Sarcoma / Q000532:radiotherapy* / Q000601:surgery*