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

March 17, 2021 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G21 3UR
        • North Glasgow University Hospitals NHS Trust
    • England
      • Birmingham, England, United Kingdom, B31 2AP
        • Royal Orthopedic Hospital NHS Trust
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
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.
Radiation: radiotherapy
radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities
Experimental: Research arm
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.
Radiation: radiotherapy
radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Time Frame: 2 years
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
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Soft tissue and bone toxicity as measured by RTOG
Time Frame: 2 years
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).
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.
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Study Chair: Martin Robinson, MD, Cancer Research Centre at Weston Park Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2006

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH14490 CRUK-VORTEX
  • CDR0000526239 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20678 (Other Identifier: NK)
  • ISRCTN76456502 (ISRCTN)
  • CRCTU-SA3002 (Other Identifier: CR UK Clinical Trials Unit, University of Birmingham)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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