Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 216
- Locations
- 6
- Primary Endpoint
- Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 120 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: radiotherapy (Radiation)
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.
Intervention: radiotherapy (Radiation)
Outcomes
Primary Outcomes
Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Time Frame: 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
Secondary Outcomes
- 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 level of disability as measured by the TESS questionnaire(2 years)
- Soft tissue and bone toxicity as measured by RTOG(2 years)
- Overall survival(defined in whole days as time from randomisation into the trial to death.)