Know Cancer

forgot password

A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)



- To assess whether there is a difference in abdominal recurrence-free survival between
retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone
and those undergoing preoperative radiotherapy followed by curative-intent surgery.


- To assess whether there is a difference in metastasis-free survival, abdominal
recurrence-free interval, and overall survival between these patients.

- To assess tumor response in patients undergoing preoperative radiotherapy.

- To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery
in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to institution and
WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following

- Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or
intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week
for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass
within 4-8 weeks after the completion of RT.

Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during
surgery to identify new prognostic factors for translational research.

After completion of study therapy, patients are followed at day 60 post-surgery and every 6
months thereafter.

Inclusion Criteria


- Histologically confirmed retroperitoneal sarcoma (RPS) by local pathologist,
imaging-guided or surgical biopsy, including the following:

- Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces
of pelvis

- Sarcoma not originated from bone structure, abdominal, or gynecological viscera

- Unifocal tumor (not multifocal disease)

- Absence of extension through the sciatic notch or across the diaphragm

- The following histological sub-types are not allowed:

- Gastrointestinal stromal tumor (GIST)

- Rhabdomyosarcomas

- Primitive neuroectodermal tumor (PNET) or other small round blue cells sarcoma

- Osteosarcoma or chondrosarcoma

- Aggressive fibromatosis

- Sarcomatoid or metastatic carcinoma

- No metastatic disease

- Untreated disease

- Tumor must be operable and suitable for radiotherapy, based on the following

- Pre-treatment CT scan/MRI and multidisciplinary consultation with surgeon,
radiation oncologist, and radiologist (anticipated macroscopically complete
resection, R0/R1 resection)

- No surgery anticipated to be R2 on the CT scan before randomization

- Must have American Society of Anesthesiologist (ASA) score ≤ 2

- None of the following unresectable criteria:

- Involvement of superior mesenteric artery

- Involvement of aorta

- Involvement of bone

- Must have radiologically measurable disease (RECIST 1.1), as confirmed by
abdomino-pelvic CT (with IV and PO contrast) or MRI (with IV contrast)


- WHO performance status 0-2

- WBC ≥ 2,500/mm^3

- Platelet count ≥ 80,000/mm^3

- Total bilirubin < 1.5 times the upper limit normal

- Calculated creatinine clearance normal

- Functional contra-lateral kidney to the side involved by the RPS as assessed by
intravenous pyelogram

- Adequate cardiac function (NYHA class I-II)

- ECG normal (without clinically significant abnormalities)

- No history of any of the following disorders:

- Bowel obstruction

- Mesenteric ischemia

- Severe chronic inflammatory bowel disease

- Negative pregnancy test

- Not pregnant or nursing concurrently and for at least 1 month after the surgery

- Fertile patients must use effective contraception during the study treatment period
and for at least 1 month after the surgery

- No co-existing malignancy within the past 5 years, except for adequately treated
basal cell carcinoma of the skin or carcinoma in situ of the cervix

- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule


- No prior surgery (excluding diagnosis biopsy), radiotherapy, or systemic therapy

- No prior abdominal or pelvic irradiation for another prior malignancy or other

- No concurrent systemic anticancer treatment (chemotherapy, molecular-targeted

- No postoperative radiotherapy planned

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Abdominal recurrence-free survival

Safety Issue:


Principal Investigator

Sylvie Bonvalot

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Sarcoma
  • adult angiosarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant mesenchymoma
  • stage I adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • Sarcoma



Dana-Farber Cancer Institute & Harvard Medical SchoolBoston, Massachusetts