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| Sponsored by: |
Cancer Research Campaign Clinical Trials Centre |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00423618 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX] |
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2006 |
OBJECTIVES:
Primary
Secondary
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.
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
Has undergone surgical resection of the tumor within the past 12 weeks
No diagnosis of any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United Kingdom | |
| North Glasgow University Hospitals NHS Trust | Recruiting |
| Glasgow, United Kingdom, G21 3UR | |
| Contact: Contact Person 44-141-201-4200 | |
| United Kingdom, England | |
| Cancer Research Centre at Weston Park Hospital | Recruiting |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Contact: Contact Person 44-141-201-4200 | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: James Wylie, MD 44-161-446-3341 | |
| Royal Orthopedic Hospital NHS Trust | Recruiting |
| Birmingham, England, United Kingdom, B31 2AP | |
| Contact: Robert Grimer, MD 44-121-685-4019 | |
| Nottingham City Hospital NHS Trust | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Michael Sokal 44-115-969-1169 | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: Contact Person 44-192-382-6111 | |
| Study Chair: | Martin Robinson, MD | Cancer Research Centre at Weston Park Hospital |
More Information
| Study ID Numbers: | CDR0000526239, CRUK-VORTEX, EU-20678, ISRCTN76456502, CRCTU-SA3002 |
| Study First Received: | January 17, 2007 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00423618 History of Changes |
| Health Authority: | Unspecified |
|
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 adult alveolar soft-part sarcoma |
|
Histiocytoma, Malignant Fibrous Fibrosarcoma Leiomyosarcoma Histiocytoma, Benign Fibrous Adjuvants, Immunologic Hemangiosarcoma Hemangiopericytoma Recurrence Malignant Fibrous Histiocytoma Sarcoma, Synovial Neoplasms, Connective and Soft Tissue |
Soft Tissue Sarcomas Malignant Mesenchymal Tumor Liposarcoma Histiocytoma Epithelioid Sarcoma Chondrosarcoma Sarcoma Synovial Sarcoma Sarcoma, Alveolar Soft Part Alveolar Soft Part Sarcoma |
|
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Sarcoma |