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

Sponsor:	NCIC Clinical Trials Group
Collaborators:	National Cancer Institute (NCI) Radiation Therapy Oncology Group
Information provided by:	National Cancer Institute (NCI)
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) radiation therapy is more effective than multiple-fraction reirradiation (many small doses of radiation therapy) in relieving bone pain caused by bone metastases.

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized
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 National Cancer Institute (NCI):

Primary Outcome Measures:

Pain relief measured by the Brief Pain Inventory at 2 months after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life assessed by the EORTC QLQ-C30 [ Designated as safety issue: No ]

Estimated Enrollment:	850
Study Start Date:	January 2004
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive single-fraction radiotherapy on day 1.	Radiation: radiation therapy Given in a single fraction or multiple fractions
Arm II: Active Comparator Patients receive multiple-fraction radiotherapy once daily on days 1-5 or on days 1-8 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.

Secondary

Compare overall pain relief in patients treated with these regimens.
Compare time to pain progression in patients treated with these regimens.
Correlate initial irradiation response with 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, 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 on day 1.
Arm II: Patients receive multiple-fraction radiotherapy once daily on days 1-5 or on days 1-8 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 in the absence of unacceptable pain progression or unacceptable toxicity.

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.

Patients are followed for up to 1 year.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 650 patients (325 per treatment arm) 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 radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions > 3cm or > 50% cortical erosion of bone diameter) AND patient is a candidate for surgical intervention.
No clinical or radiological evidence of spinal cord compression

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
Must be accessible for treatment follow-up

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 prior 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

Show 167 Study Locations

Sponsors and Collaborators

NCIC Clinical Trials Group

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

Study Chair:	Edward L.W. Chow, MD	Edmond Odette Cancer Centre at Sunnybrook
Study Chair:	William F. Hartsell, MD	Alexian Brothers Radiation Oncology

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 ( Regulatory Affairs Associate )
Study ID Numbers:	CDR0000357423, CAN-NCIC-SC20, RTOG-0433, TROG 03.08
Study First Received:	April 7, 2004
Last Updated:	November 7, 2009
ClinicalTrials.gov Identifier:	NCT00080912 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

bone metastases
pain

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on November 09, 2009