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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sarcoma

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

Phase: Phase 3

Status: Completed

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

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Primary Purpose: Treatment

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.

Eligibility

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

Locations and Contacts

North Glasgow University Hospitals NHS Trust, Glasgow G21 3UR, United Kingdom

Royal Orthopedic Hospital NHS Trust, Birmingham, England B31 2AP, United Kingdom

Christie Hospital, Manchester, England M20 4BX, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom

Nottingham City Hospital, Nottingham, England NG5 1PB, United Kingdom

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom

Additional Information

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

Starting date: March 2006
Last updated: August 9, 2013

Page last updated: August 23, 2015

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