Clinical Trial: Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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.


Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Current Primary Outcome:

  • Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) [ Time Frame: 2 years ]
  • Time to local recurrence [ Time Frame: time from randomisation into the trial to the occasion when a local recurrence is confirmed by biopsy. For those patients who are not observed to have a local recurrence during the course of the study, the time to local recu ]


Original Primary Outcome:

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


Current Secondary Outcome:

  • Soft tissue and bone toxicity as measured by RTOG [ Time Frame: 2 years ]
  • Disease-free survival [ Time Frame: defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first). ]
  • Overall survival [ Time Frame: defined in whole days as time from randomisation into the trial to death. ]
  • Overall level of disability as measured by the TESS questionnaire [ Time Frame: 2 years ]


Original 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


Information By: Sheffield Teaching Hospitals NHS Foundation Trust

Dates:
Date Received: January 17, 2007
Date Started: March 2006
Date Completion: December 2018
Last Updated: January 19, 2017
Last Verified: January 2017