Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy in Treating Patients Who Have Undergone Surgery for Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet

Basic Trial Information

Objectives

Primary

1. Determine if reduced volume adjuvant radiotherapy increases limb function without compromising local control in patients with previously resected extremity soft tissue sarcoma.

Secondary

1. Determine the toxicity of this regimen in these patients.
2. Determine the overall level of disability in patients treated with this regimen.
3. Determine the disease-free survival and overall survival of these patients.

Entry Criteria

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

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior radiotherapy to the local site
• No prior neoadjuvant or adjuvant chemotherapy

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

Expected Enrollment

A total of 400 patients will be accrued for this study.

Outcomes

Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Time to local recurrence

Soft tissue and bone toxicity as measured by RTOG
Disease-free survival
Overall survival
Overall level of disability as measured by the TESS questionnaire

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

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit - Birmingham

Martin Robinson, MD, Protocol chair		Ph: 44-114-226-5221

United Kingdom
	Glasgow
	North Glasgow University Hospitals NHS Trust
		Contact Person	Ph:  44-141-201-4200
England
	Birmingham
	Royal Orthopedic Hospital NHS Trust
		Robert Grimer, MD	Ph:  44-121-685-4019
	Manchester
	Christie Hospital
		James Wylie, MD	Ph:  44-161-446-3341
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph:  44-192-382-6111
	Nottingham
	Nottingham City Hospital
		Michael Sokal	Ph:  44-115-969-1169
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Contact Person	Ph:  44-141-201-4200
		Martin Robinson, MD	Ph:  44-114-226-5221

Registry Information
Official Title		Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients with Extremity Soft Tissue Sarcoma [VORTEX]
Trial Start Date		2006-03-08
Registered in ClinicalTrials.gov		NCT00423618
Date Submitted to PDQ		2006-12-08
Information Last Verified		2007-12-04

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