Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma (VORTEX)

NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Sarcoma

Treatments: Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00423618

CRCTU-SA3002 (Other Identifier)

STH14490 CRUK-VORTEX

EU-20678 (Other Identifier)

CDR0000526239 (Registry Identifier)

ISRCTN76456502 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 16 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Control arm

Active Comparator group

Description:

Radiotherapy Conventional treatment arm A total of 33 fractions each of 2Gy should be given once a day for 5 days per week over 6 weeks and 3 days in week 7, totalling 66Gy. The first 50 Gy in 25 fractions will be given to CTV1 and subsequent 16 Gy in 8 fractions will be delivered to CTV2.

Treatment:

Radiation: radiotherapy

Research arm

Experimental group

Description:

Radiotherapy Research arm A total of 33 fractions each of 2Gy should be given once a day for 5 days per week over 6 weeks and 3 days in week 7, totalling 66Gy. The 66Gy in 33 fractions will be delivered to CTV2 alone. No attempt will be made to include drain/biopsy sites or the surgical scar.

Treatment:

Radiation: radiotherapy