Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases
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| ClinicalTrials.gov Identifier: NCT00080912 |
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Recruitment Status :
Completed
First Posted : April 8, 2004
Results First Posted : February 26, 2015
Last Update Posted : April 14, 2020
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Cancer Pain | Radiation: radiation therapy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 850 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | January 7, 2004 |
| Actual Primary Completion Date : | April 10, 2013 |
| Actual Study Completion Date : | January 16, 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Patients receive single-fraction radiotherapy (8 Gy) on day 1.
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Radiation: radiation therapy
Given in a single fraction or multiple fractions |
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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.
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Radiation: radiation therapy
Given in a single fraction or multiple fractions |
- Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment [ Time Frame: 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%.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed malignancy
- Diagnosis by needle biopsy, bone marrow biopsy, cytology, or surgical biopsy or resection
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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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080912
| 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 | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| CHUM - Hopital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| McGill University - Dept. Oncology | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Centre hospitalier universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Edward LW Chow, MD | Toronto Sunnybrook Regional Cancer Centre | |
| 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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00080912 |
| Obsolete Identifiers: | NCT00797173 |
| Other Study ID Numbers: |
SC20 CAN-NCIC-SC20 ( Other Identifier: PDQ ) RTOG-0433 ( Other Identifier: RTOG ) TROG-03.08 ( Other Identifier: TROG ) CDR0000357423 ( Other Identifier: PDQ ) |
| First Posted: | April 8, 2004 Key Record Dates |
| Results First Posted: | February 26, 2015 |
| Last Update Posted: | April 14, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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bone metastases pain |
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