Radiation Therapy in Treating Patients Who Have Undergone Surgery for Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet
Recruitment status was Recruiting
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy to a smaller area of tissue surrounding the tumor is as effective as giving radiation therapy to a wider area of tissue surrounding the tumor in treating soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying giving external-beam radiation therapy to a small area of tissue surrounding the tumor to see how well it works compared with giving external-beam radiation therapy to a wider area of tissue surrounding the tumor in treating patients who have undergone surgery for soft tissue sarcoma of the arms, hands, legs, or feet.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX] |
- Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) [ Designated as safety issue: No ]
- Time to local recurrence [ Designated as safety issue: No ]
- Soft tissue and bone toxicity as measured by RTOG [ Designated as safety issue: Yes ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Overall level of disability as measured by the TESS questionnaire [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2006 |
OBJECTIVES:
Primary
- Determine if reduced volume adjuvant radiotherapy increases limb function without compromising local control in patients with previously resected extremity soft tissue sarcoma.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the overall level of disability in patients treated with this regimen.
- Determine the disease-free survival and overall survival of these patients.
OUTLINE: This is a randomized, controlled, prospective, multicenter study. Patients are stratified according to tumor grade (1 vs 2 vs 3), adequacy of surgical clearance (R0 vs R1), and treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo external beam radiotherapy (EBRT), including full margins, once daily 5 days a week for 6½ weeks .
- Arm II: Patients undergo EBRT as in arm I but only reduced margins are included.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma meeting the following criteria:
Lesion originates in extremity
Upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
- No lesions of the chest wall arising adjacent to the scapula but not originating in the shoulder bone
- Lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
- Imaging and pathology from first surgery are required
Has undergone surgical resection of the tumor within the past 12 weeks
- No macroscopic tumor in situ after surgery
- Microscopically irradical surgical margin allowed
- Excisional biopsy with positive margins or other inadequate surgery (macroscopically involved margins) allowed only after further definitive re-excision
- Positive margins and no further surgery possible except amputation or major functional loss allowed provided no macroscopic residual disease is present
- Local recurrence within 3 months of prior surgery (or other treatment) allowed provided patient undergoes subsequent re-excision
No diagnosis of any of the following:
- Rhabdomyosarcoma (alveolar or embryonal)
- Primitive neuroectodermal tumor
- Soft tissue Ewing's sarcoma
- Extraskeletal osteosarcoma
- Aggressive fibromatosis (desmoid tumors)
- Dermatofibrosarcoma protuberans
- Gorlin's syndrome
- No regional nodal disease or unequivocal distant metastasis
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No other major medical illness that would preclude study treatment
- No other malignancy except adequately treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the local site
- No prior neoadjuvant or adjuvant chemotherapy
Contacts and Locations| United Kingdom | |
| Royal Orthopedic Hospital NHS Trust | Recruiting |
| Birmingham, England, United Kingdom, B31 2AP | |
| Contact: Robert Grimer, MD 44-121-685-4019 | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: James Wylie, MD 44-161-446-3341 | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: Contact Person 44-192-382-6111 | |
| Nottingham City Hospital | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Michael Sokal 44-115-969-1169 | |
| Cancer Research Centre at Weston Park Hospital | Recruiting |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Contact: Contact Person 44-141-201-4200 | |
| North Glasgow University Hospitals NHS Trust | Recruiting |
| Glasgow, United Kingdom, G21 3UR | |
| Contact: Contact Person 44-141-201-4200 | |
| Study Chair: | Martin Robinson, MD | Cancer Research Centre at Weston Park Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00423618 History of Changes |
| Other Study ID Numbers: | CDR0000526239, CRUK-VORTEX, EU-20678, ISRCTN76456502, CRCTU-SA3002 |
| Study First Received: | January 17, 2007 |
| Last Updated: | August 5, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult alveolar soft-part sarcoma recurrent adult soft tissue sarcoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma adult synovial sarcoma adult angiosarcoma adult epithelioid sarcoma |
adult extraskeletal chondrosarcoma adult leiomyosarcoma adult liposarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult malignant mesenchymoma adult fibrosarcoma adult neurofibrosarcoma |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013