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SarcomaPhase 3VORTEXNCT00423618

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

A Phase 3 study testing radiotherapy in people with Sarcoma, run by Sheffield Teaching Hospitals NHS Foundation Trust at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 120 years
Conditions the study is for
Sarcoma
What is being tested?
radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
6 sitesUnited Kingdom
Study dates
Mar 2006to 31 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • Royal Orthopedic Hospital NHS Trust

    Birmingham, England, B31 2AP

  • North Glasgow University Hospitals NHS Trust

    Glasgow, G21 3UR

  • Christie Hospital

    Manchester, England, M20 4BX

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital

    Nottingham, England, NG5 1PB

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Sarcoma
Being tested
radiotherapy
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
Medical subject headings
Sarcoma, Sarcoma, Synovial, Hemangiosarcoma, Chondrosarcoma, Extraskeletal Myxoid, Leiomyosarcoma, Liposarcoma, Histiocytoma, Malignant Fibrous, Hemangiopericytoma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiotherapyRadiation

    radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

Study groups in NCT00423618
Study groupRoleWhat they receive
Control armActive comparatorRadiotherapy 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.
Receives: Radiation: radiotherapy
Research armExperimentalRadiotherapy 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.
Receives: Radiation: radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

  2. Time to local recurrence

    Measured: 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 outcomes (4)

  1. Soft tissue and bone toxicity as measured by RTOG

    Measured: 2 years

  2. Disease-free survival

    Measured: defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first).

  3. Overall survival

    Measured: defined in whole days as time from randomisation into the trial to death.

  4. Overall level of disability as measured by the TESS questionnaire

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startMar 2006
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423618
Sponsor's protocol ID
STH14490 CRUK-VORTEX
Other IDs
CDR0000526239, EU-20678, ISRCTN76456502, CRCTU-SA3002
Acronym
VORTEX
Status last verified
Mar 2021
First submitted
17 Jan 2007
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Simoes R, Gulliford S, Seddon B, Dehbi HM, Robinson M, Forsyth S, Hughes A, Gaunt P, Nguyen TG, Elston S, Mohammed K, Zaidi S, Miles E, Hoskin P, Harrington K, Miah A. Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose-volume constraints development: a study protocol. BMJ Open. 2024 Aug 9;14(8):e083617. doi: 10.1136/bmjopen-2023-083617.

    PubMed 39122389

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radiotherapy in people with Sarcoma, run by Sheffield Teaching Hospitals NHS Foundation Trust at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00423618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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