Single-Fraction Compared With Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases

This study has been completed.
Sponsor:
Collaborators:
Radiation Therapy Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
Cancer Research UK
Dutch Bone Metastasis Study Group
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00080912
First received: April 7, 2004
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases.

PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if it works as well as multiple-dose radiation therapy in treating patients previously irradiated with painful bone metastases.


Condition Intervention Phase
Metastatic Cancer
Pain
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Pain relief measured by the Brief Pain Inventory at 2 months after treatment [ Time Frame: 8.2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessed by the EORTC QLQ-C30 [ Time Frame: 8.2 years ] [ Designated as safety issue: No ]

Enrollment: 850
Study Start Date: January 2004
Study Completion Date: January 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive single-fraction radiotherapy (8 Gy) on day 1.
Radiation: radiation therapy
Given in a single fraction or multiple fractions
Active Comparator: Arm II
Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
Radiation: radiation therapy
Given in a single fraction or multiple fractions

Detailed Description:

OBJECTIVES:

Primary

  • Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases at 2 months after treatment.

Secondary

  • Compare overall pain relief in patients treated with these regimens.
  • Compare time to pain progression in patients treated with these regimens.
  • Assess relationship between response to initial radiation and pain relief after re-irradiation in these patients.
  • Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens (patients in Canada, France, the Netherlands, and patients registered through RTOG).
  • Determine characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens.
  • Monitor the incidence of acute severe radiation-related side effects in patients treated with these regimens.
  • Monitor the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to initial radiotherapy (yes vs no), initial fractionation (single fraction vs multiple fraction), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive single-fraction radiotherapy (8Gy) on day 1.
  • Arm II: Patients receive multiple-fraction radiotherapy (to a total of 20Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

At least 4 weeks after the first re-treatment, patients in both arms may receive a second re-treatment at the discretion of the treating oncologist.

Patients complete a Brief Pain Inventory questionnaire at baseline, on days 7 and 14, monthly during months 1-6, and at months 9 and 12. Acute Toxicities are assessed on days 7 and 14. Quality of Life is assessed at baseline and then monthly during months 1-6 for patients from participating groups.

Patients are followed for up to 1 year.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignancy

    • Diagnosis by needle biopsy, bone marrow biopsy, cytology, or surgical biopsy or resection
  • Bone metastases at clinically painful areas confirmed by any of the following:

    • Plain radiographs
    • Radionuclide bone scans
    • CT scans
    • Magnetic resonance imaging
  • Worst pain score of ≥ 2/10 using the baseline Brief Pain Inventory
  • Pain arising from previously irradiated metastases and not from progressive disease in adjoining or remote areas
  • Initial radiotherapy field is reproducible for re-irradiation

    • Current treatment field for palliative radiotherapy must be the same size or smaller than the initial treatment field
  • No clinical or radiological evidence of pathological fractures in the target site extremities.
  • No radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions > 3cm or > 50% cortical erosion of bone diameter) if target site AND patient is a candidate for surgical intervention.
  • No clinical or radiological evidence of spinal cord compression at target site.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception
  • Able and willing to complete quality of life questionnaire in English, French, Dutch, or Spanish (if randomized by Canadian, Dutch, French or RTOG centre)
  • Must be accessible for treatment follow-up
  • Informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No more than 1 prior course of radiotherapy to the target site
  • No prior radiotherapy dose ≥ 24 Gy in 6 fractions, 27 Gy in 8 fractions, or 30 Gy in 10 fractions to the spine or any part of the pelvis encompassing small or large bowel and/or the rectum, if these sites are being treated on study

    • Initial doses of 24 Gy in 6 fractions, 27 Gy in 8 fractions or 30 Gy in 10 fractions to the acetabulum or hip and proximal femur allowed as long as the medial field border of the initial treatment did not cross midline
  • No prior radiotherapy dose > 30Gy in 10 fractions to the ribs or extremities if these sites are being treated on study
  • More than 30 days since prior strontium chloride Sr 89
  • More than 30 days since prior half-body radiotherapy, including the current re-irradiation field
  • At least 4 weeks since initial radiotherapy

Surgery

  • No prior palliative surgery in treatment area
  • No concurrent surgical intervention on treatment area

Other

  • No prior participation on this protocol
  • No plan to make an immediate change in analgesic regimen
  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: NCT00080912

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
NCIC Clinical Trials Group
Radiation Therapy Oncology Group
Trans-Tasman Radiation Oncology Group (TROG)
Cancer Research UK
Dutch Bone Metastasis Study Group
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Edward LW Chow, MD Edmond Odette Cancer Centre at Sunnybrook
Study Chair: William F. Hartsell, MD Advocate Good Samaratin Cancer Centre
Study Chair: Daniel Roos, MD Royal Adelaide Hospital Cancer Centre
Study Chair: Yvette von der Linden Radiotherapeutic Institution Friesland
Study Chair: Peter Hoskin Mount Vernon Cancer Centre
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00080912     History of Changes
Obsolete Identifiers: NCT00797173
Other Study ID Numbers: SC20, CAN-NCIC-SC20, RTOG-0433, TROG-03.08, CDR0000357423
Study First Received: April 7, 2004
Last Updated: January 16, 2014
Health Authority: Canada: NCIC Clinical Trials Group

Keywords provided by NCIC Clinical Trials Group:
bone metastases
pain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014