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

NCT00423618 | Completed Phase 3 DMC

• 5 other identifiers: STH14490 CRUK-VORTEXCDR0000526239EU-20678ISRCTN76456502CRCTU-SA3002
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 6

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.

Conditions

Sarcoma

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Control arm

ACTIVE COMPARATOR

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

Research arm

EXPERIMENTAL

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

Interventions

radiotherapy RADIATION

radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

Control arm; Research arm

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (6)

Royal Orthopedic Hospital NHS Trust

Birmingham, England, B31 2AP, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

North Glasgow University Hospitals NHS Trust

Glasgow, G21 3UR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39122389 DERIVED

Related Links

• Clinical trial summary from Cancer Research UK

MeSH Terms

Conditions

Sarcoma; Sarcoma, Synovial; Hemangiosarcoma; Chondrosarcoma, Extraskeletal Myxoid; Leiomyosarcoma; Liposarcoma; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant; Malignant mesenchymal tumor; Fibrosarcoma; Neurofibrosarcoma; Sarcoma, Alveolar Soft Part

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Vascular Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Histiocytoma; Neoplasms, Fibrous Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Martin Robinson, MD

  Cancer Research Centre at Weston Park Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: March 1, 2006
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)