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

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00423618

Collaborator

(none)

216

Enrollment

Locations

Arms

154

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Radiation: radiotherapy	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) [2 years]
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 Outcome Measures

Soft tissue and bone toxicity as measured by RTOG [2 years]
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).]
Overall survival [defined in whole days as time from randomisation into the trial to death.]
Overall level of disability as measured by the TESS questionnaire [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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