Clinical trial NCT00423618: Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
Official title: Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2007-01-18
Enrollment: 216
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
timeFrame: 2 years
measure: Time to local recurrence
timeFrame: 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:
measure: Soft tissue and bone toxicity as measured by RTOG
timeFrame: 2 years
measure: Disease-free survival
timeFrame: defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first).
measure: Overall survival
timeFrame: defined in whole days as time from randomisation into the trial to death.
measure: Overall level of disability as measured by the TESS questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Royal Orthopedic Hospital NHS Trust
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Glasgow
country: United Kingdom
facility: North Glasgow University Hospitals NHS Trust
Study officials:
affiliation: Cancer Research Centre at Weston Park Hospital
name: Martin Robinson, MD
role: STUDY_CHAIR
References: