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

Sponsor:	NCIC Clinical Trials Group
Collaborators:	National Cancer Institute (NCI) 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

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 III

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 ]

Estimated Enrollment:	850
Study Start Date:	January 2004
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080912

Contacts

Contact: Ralph Meyer, M.D

613-533-6430

rmeyer@ctg.queensu.ca

Locations

Canada, Alberta
Tom Baker Cancer Centre	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Marc Kerba 403-521-3164
Cross Cancer Institute	Withdrawn
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
The Vitalite Health Network - Dr. Leon Richard	Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Fernando Rojas 506-862-4030
Atlantic Health Sciences Corporation	Withdrawn
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre	Withdrawn
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
QEII Health Sciences Center	Withdrawn
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences	Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: William G. McMillan 905-387-9495
Cancer Centre of Southeastern Ontario at Kingston	Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Catherine de Metz 613-549-6666 ext 4509
Grand River Regional Cancer Centre	Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Vas R. Basrur 519-749-4380 ext 5489
Ottawa Health Research Institute - General Division	Withdrawn
Ottawa, Ontario, Canada, K1H 8L6
Thunder Bay Regional Health Science Centre	Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Margaret L. Anthes 807-684-7211
Odette Cancer Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Edward L.W. Chow 416-480-4998
Univ. Health Network-Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrea Bezjak 416-946-2132
Windsor Regional Cancer Centre	Withdrawn
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
CHUM - Hopital Notre-Dame	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Isabelle Roy 514-890-5420
McGill University - Dept. Oncology	Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Marc David 514-934-8040 ext 43191
Centre hospitalier universitaire de Sherbrooke	Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Abdenour Nabid 819-346-1110 ext 14602
Canada, Saskatchewan
Allan Blair Cancer Centre	Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Rashmi Koul 306-766-2288

Sponsors and Collaborators

NCIC Clinical Trials Group

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Chow E, Hoskin PJ, Wu J, Roos D, van der Linden Y, Hartsell W, Vieth R, Wilson C, Pater J. A phase III international randomised trial comparing single with multiple fractions for re-irradiation of painful bone metastases: National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) SC 20. Clin Oncol (R Coll Radiol). 2006 Mar;18(2):125-8. Review. No abstract available.

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:	November 25, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by NCIC Clinical Trials Group:

bone metastases
pain

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes

Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012