Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080912
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2004-04-07
Brief Title:
Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-SC20 | OTHER | None | None |
| RTOG-0433 | OTHER | None | None |
| TROG-0308 | OTHER | None | None |
| CDR0000357423 | OTHER | PDQ | None |