Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Radiation Therapy in Treating Patients Who Have Undergone Surgery for Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00423618
First received: January 17, 2007
Last updated: August 9, 2013
Last verified: December 2007
  Purpose

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 Intervention Phase
Sarcoma
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) [ Designated as safety issue: No ]
  • Time to local recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Soft tissue and bone toxicity as measured by RTOG [ Designated as safety issue: Yes ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Overall level of disability as measured by the TESS questionnaire [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2006
Study Completion Date: July 2011
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423618

Locations
United Kingdom
Royal Orthopedic Hospital NHS Trust
Birmingham, England, United Kingdom, B31 2AP
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
North Glasgow University Hospitals NHS Trust
Glasgow, United Kingdom, G21 3UR
Sponsors and Collaborators
Cancer Research Campaign Clinical Trials Centre
Investigators
Study Chair: Martin Robinson, MD Cancer Research Centre at Weston Park Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00423618     History of Changes
Other Study ID Numbers: CRUK-VORTEX, CDR0000526239, EU-20678, ISRCTN76456502, CRCTU-SA3002
Study First Received: January 17, 2007
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult alveolar soft-part sarcoma
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

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on November 25, 2014