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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Orthopedic Hospital NHS Trust
  • Christie Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital
  • Cancer Research Centre at Weston Park Hospital
  • North Glasgow University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Research arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Soft tissue and bone toxicity as measured by RTOG
Disease-free survival
Overall survival
Overall level of disability as measured by the TESS questionnaire

Full Information

First Posted
January 17, 2007
Last Updated
March 17, 2021
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00423618
Brief Title
Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
Acronym
VORTEX
Official Title
Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2006 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Active Comparator
Arm 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.
Arm Title
Research arm
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities
Primary Outcome Measure Information:
Title
Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Time Frame
2 years
Title
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
Secondary Outcome Measure Information:
Title
Soft tissue and bone toxicity as measured by RTOG
Time Frame
2 years
Title
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).
Title
Overall survival
Time Frame
defined in whole days as time from randomisation into the trial to death.
Title
Overall level of disability as measured by the TESS questionnaire
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Robinson, MD
Organizational Affiliation
Cancer Research Centre at Weston Park Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Orthopedic Hospital NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B31 2AP
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
North Glasgow University Hospitals NHS Trust
City
Glasgow
ZIP/Postal Code
G21 3UR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-the-size-of-the-radiotherapy-treatment-area-for-people-with-soft-tissue-sarcoma
Description
Clinical trial summary from Cancer Research UK

Learn more about this trial

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

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