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

Phase 3
16 Years
Open (Enrolling)

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Trial Information

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



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


- 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.

Inclusion Criteria


- 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

- 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


- 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


- See Disease Characteristics

- No prior radiotherapy to the local site

- No prior neoadjuvant or adjuvant chemotherapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Martin Robinson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Research Centre at Weston Park Hospital



Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Sarcoma
  • 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
  • Sarcoma