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

Condition(s) targeted: Sarcoma

Intervention: adjuvant therapy (Procedure); radiation therapy (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cancer Research Campaign Clinical Trials Centre

Official(s) and/or principal investigator(s):
Martin Robinson, MD, Study Chair, Affiliation: Cancer Research Centre at Weston Park Hospital

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.

Official title: Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]

Study design: Treatment, Randomized, Active Control

Primary outcome:

Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)

Time to local recurrence

Secondary outcome:

Soft tissue and bone toxicity as measured by RTOG

Disease-free survival

Overall survival

Overall level of disability as measured by the TESS questionnaire

Detailed description: 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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

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

North Glasgow University Hospitals NHS Trust, Glasgow G21 3UR, United Kingdom; Recruiting
Contact Person, Phone: 44-141-201-4200

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom; Recruiting
Contact Person, Phone: 44-141-201-4200

Christie Hospital, Manchester, England M20 4BX, United Kingdom; Recruiting
James Wylie, MD, Phone: 44-161-446-3341

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom; Recruiting
Contact Person, Phone: 44-192-382-6111

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom; Recruiting
Michael Sokal, Phone: 44-115-969-1169

Royal Orthopedic Hospital NHS Trust, Birmingham, England B31 2AP, United Kingdom; Recruiting
Robert Grimer, MD, Phone: 44-121-685-4019

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2006
Last updated: July 23, 2008