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

Sarcoma Clinical Trial

— VORTEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423618
• Other study ID #: STH14490 CRUK-VORTEX
• Secondary ID: CDR0000526239EU-
• Status: Completed
• Phase: Phase 3
• Start date: March 2006
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2021
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

Radiation:
• radiotherapy
radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

Locations

Country	Name	City	State
United Kingdom	Royal Orthopedic Hospital NHS Trust	Birmingham	England
United Kingdom	North Glasgow University Hospitals NHS Trust	Glasgow
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)		2 years
Primary	Time to local recurrence		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	Soft tissue and bone toxicity as measured by RTOG		2 years
Secondary	Disease-free survival		defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first).
Secondary	Overall survival		defined in whole days as time from randomisation into the trial to death.
Secondary	Overall level of disability as measured by the TESS questionnaire		2 years

External Links

•   Clinical trial summary from Cancer Research UK