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

Not Applicable

Completed

• Conditions: Metastatic Cancer; Pain
• Interventions: Radiation: radiation therapy

• Registration Number: NCT00080912
• Lead Sponsor: NCIC Clinical Trials Group

Brief 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.

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.

Study Timeline

• Study Start: 2004-01-22
• Study First Submitted: 2004-04-07
• Study First Submitted QC: 2004-04-07
• Study First Posted: 2004-04-08
• Primary Completion: 2013-04-10
• Study Completion: 2014-01-16
• Results First Submitted: 2015-02-11
• Results First Submitted QC: 2015-02-11
• Results First Posted: 2015-02-26
• Status Verified: 2020-04
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	radiation therapy	Patients receive single-fraction radiotherapy (8 Gy) on day 1.
Arm II	radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment	2 months	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%.

Trial Locations

Locations (12)

CHUM - Hopital Notre-Dame; 🇨🇦 Montreal, Quebec, Canada

The Vitalite Health Network - Dr. Leon Richard; 🇨🇦 Moncton, New Brunswick, Canada

Allan Blair Cancer Centre; 🇨🇦 Regina, Saskatchewan, 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

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Thunder Bay Regional Health Science Centre; 🇨🇦 Thunder Bay, Ontario, Canada

McGill University - Dept. Oncology; 🇨🇦 Montreal, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada