Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis
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| ClinicalTrials.gov Identifier: NCT00091351 |
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Recruitment Status :
Completed
First Posted : September 9, 2004
Last Update Posted : July 6, 2016
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.
PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcoma | Procedure: conventional surgery Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
Primary
- Compare progression-free survival of patients with primary soft tissue sarcoma of the retroperitoneum or pelvis treated with surgery with vs without preoperative radiotherapy.
Secondary
- Compare the toxicity and complications associated with these regimens in these patients.
- Compare the rate of microscopically complete surgical resection in patients treated with these regimens.
- Compare the overall survival rate of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor grade (low [G1] vs intermediate [G2] vs high [G3/4]), tumor size (< 15 cm vs ≥ 15 cm), and tumor histology (liposarcoma vs non-liposarcoma). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgery.
- Arm II: Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 370 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS) |
| Study Start Date : | August 2004 |
| Actual Primary Completion Date : | February 2006 |
| Actual Study Completion Date : | February 2006 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: surgery
Patients undergo surgery. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years. |
Procedure: conventional surgery |
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Experimental: radiation + surgery
Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years. |
Procedure: conventional surgery Radiation: radiation therapy |
- Progression-free survival at 5 years [ Time Frame: at 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa)
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The following histologies are eligible:
- Alveolar soft part sarcoma
- Anaplastic sarcoma
- Angiosarcoma
- Atypical lipomatous tumor (low-grade liposarcoma)
- Clear cell sarcoma
- Epithelioid sarcoma
- Fibrosarcoma
- Leiomyosarcoma
- Liposarcoma (all subtypes)
- Malignant fibrous histiocytoma
- Malignant peripheral nerve sheath tumor
- Myxofibrosarcoma
- Neurofibrosarcoma
- Spindle cell sarcoma
- Synovial sarcoma
- Unclassified sarcoma
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The following histologies are not eligible:
- Rhabdomyosarcoma
- Extraosseous Ewing's sarcoma
- Primitive neuroectodermal tumor
- Osteosarcoma
- Chondrosarcoma
- Aggressive fibromatosis (desmoid tumor)
- Gastrointestinal stromal tumor
- Sarcomatoid carcinoma
- Hemangiopericytoma
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Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that ≥ 90% of the tumor volume is located within the retroperitoneal space
- No bowel obstruction OR history of previous bowel obstruction attributed to retroperitoneal tumor
- Primary non-visceral retroperitoneal masses consistent with sarcoma allowed provided diagnoses of carcinoma, melanoma, and lymphoma are excluded by immunohistochemistry
- Measurable gross disease by abdominopelvic CT scan (with IV and oral contrast) or MRI (with IV contrast)
- Patients must have undergone radiotherapy consultation within the past 30 days to confirm the feasibility of preoperative external-beam radiotherapy
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Patients must have undergone surgical consultation within the past 30 days to confirm and document the feasibility of macroscopically complete resection
- No prior macroscopically incomplete (R2) resection (i.e., partial debulking or subtotal tumor resection with gross residual disease)
- No pelvic sarcoma extending through the sciatic notch
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No clinical or radiographic evidence of probable metastatic disease
- Equivocal pulmonary or liver lesion allowed provided the likelihood of metastatic disease is small
- No sarcoma arising from bone or any retroperitoneal viscus (except the kidney)
- No sarcoma extending across the diaphragm into the thorax
- No recurrent retroperitoneal tumor
- No multifocal disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1 OR
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 2,500/mm^3
- Platelet count ≥ 80,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN
- Albumin normal* NOTE: *Higher levels allowed
Renal
- Creatinine normal
- BUN normal
- Functional kidney confirmed by intravenous pyelogram and/or differential renal isotope scan
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No other malignancy within the past 5 years (except effectively treated basal cell or squamous cell skin cancer) unless patient was curatively treated AND is at low risk for recurrence
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No concurrent chemotherapy for primary tumor
Radiotherapy
- No prior abdominal or pelvic irradiation
- No concurrent intraoperative or postoperative radiotherapy for primary tumor
Surgery
- See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091351
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| Study Chair: | Peter Pisters, MD | M.D. Anderson Cancer Center |
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00091351 |
| Other Study ID Numbers: |
ACOSOG-Z9031 ACOSOG-Z9031 CDR0000387803 ( Registry Identifier: NCI Physician Data Query ) |
| First Posted: | September 9, 2004 Key Record Dates |
| Last Update Posted: | July 6, 2016 |
| Last Verified: | July 2016 |
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adult alveolar soft-part sarcoma adult angiosarcoma adult epithelioid sarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma |
adult neurofibrosarcoma adult synovial sarcoma adult malignant fibrous histiocytoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma |
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Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |