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

Pain Clinical Trial

Official title:

A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080912
• Other study ID #: SC20
• Secondary ID: CAN-NCIC-SC20RTO
• Status: Completed
• Phase: N/A
• Start date: January 22, 2004
• Est. completion date: January 16, 2014

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00797173

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: January 16, 2014
• Est. primary completion date: April 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pain

Intervention

Radiation:
• radiation therapy
Given in a single fraction or multiple fractions

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston	Kingston	Ontario
Canada	Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	The Vitalite Health Network - Dr. Leon Richard	Moncton	New Brunswick
Canada	CHUM - Hopital Notre-Dame	Montreal	Quebec
Canada	McGill University - Dept. Oncology	Montreal	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	Univ. Health Network-Princess Margaret Hospital	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group	Assistance Publique - Hôpitaux de Paris, Cancer Research UK, National Cancer Institute (NCI), Radiation Therapy Oncology Group, Trans Tasman Radiation Oncology Group

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. doi: 10.1016/j.clon.2005.11.014. No abstract available. — View Citation

Chow E, van der Linden YM, Roos D, Hartsell WF, Hoskin P, Wu JS, Brundage MD, Nabid A, Tissing-Tan CJ, Oei B, Babington S, Demas WF, Wilson CF, Meyer RM, Chen BE, Wong RK. Single versus multiple fractions of repeat radiation for painful bone metastases: a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment	The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation. A complete response was defined as a Brief Pain Inventory worst-pain score of zero with no associated increase in daily oral morphine equivalent. A partial response was defined as pain that persisted after treatment, either with a worst-pain score reduction of 2 or more and no increase in daily oral morphine equivalent consumption, or no increase in pain and a reduction in daily oral morphine equivalent consumption of at least 25%.	2 months