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

NCT ID: NCT00423618

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

radiotherapy

Intervention Type: RADIATION

radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

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.

Group Type: EXPERIMENTAL

radiotherapy

Intervention Type: RADIATION

radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

Interventions

radiotherapy

radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Robinson, MD

Role: STUDY_CHAIR

Cancer Research Centre at Weston Park Hospital

Locations

Royal Orthopedic Hospital NHS Trust

Birmingham, England, 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, United Kingdom

North Glasgow University Hospitals NHS Trust

Glasgow, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39122389 (View on PubMed)

Related Links

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

Clinical trial summary from Cancer Research UK

Other Identifiers

CDR0000526239

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20678

Identifier Type: OTHER

Identifier Source: secondary_id

ISRCTN76456502

Identifier Type: REGISTRY

Identifier Source: secondary_id

CRCTU-SA3002

Identifier Type: OTHER

Identifier Source: secondary_id

STH14490 CRUK-VORTEX

Identifier Type: -

Identifier Source: org_study_id