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| Sponsored by: |
International Atomic Energy Agency |
|---|---|
| Information provided by: | International Atomic Energy Agency |
| ClinicalTrials.gov Identifier: | NCT00610272 |
Purpose
Bone metastasis is one of the most frequent end complications of the cancer. Radiation therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both single and multiple bone metastasisis is widely used, but optimization of the single dose fractionation is needed. Two different regimens of radiotherapy dose fractionation will be investigated in both single and multiple bone metastasis and endpoints will include pain relief as well as toxicity and quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Bone Metastasis |
Radiation: radiotherapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis |
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
|
Radiation: radiotherapy
4 Gy or 8 Gy or 12 Gy
|
|
2: Active Comparator
8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
|
Radiation: radiotherapy
4 Gy or 8 Gy or 12 Gy
|
|
3: Active Comparator
8 Gy in a single fraction; retreatments > 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI);
|
Radiation: radiotherapy
4 Gy or 8 Gy or 12 Gy
|
|
4: Experimental
12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments > 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;
|
Radiation: radiotherapy
4 Gy or 8 Gy or 12 Gy
|
PROTOCOL SCHEMA
Group A Treatment of single site of painful bone metastasis:
Arm 1: 4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
Arm 2: 8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
Group B Treatment of multiple bone metastasis: lower hemibody radiotherapy (LHBI):
Arm 3: 8 Gy in a single fraction; retreatments > 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI);
Arm 4: 12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments > 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Branislav Jeremic, MD, PhD | +4312600 ext 21666 | b.jeremic@iaea.org |
| Contact: Chandra Soysa | +4312600 ext 21656 | C.Soysa@iaea.org |
| Spain | |
| Francesc Casas | Recruiting |
| Barcelona, Spain | |
| Contact: Francesc casas, MD FCASAS@clinic.ub.es | |
| Study Chair: | Branislav Jeremic, Md, PhD | International Atomic Energy Agency |
More Information
| Responsible Party: | Department of NA ( International Atomic Energy Agency ) |
| Study ID Numbers: | E33028 |
| Study First Received: | January 25, 2008 |
| Last Updated: | February 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00610272 |
| Health Authority: | Austria: Independent Data Monitoring Committee - IAEA |
|
single bone metastasis multiple bone metastasis pain relief radiotherapy |
|
Musculoskeletal Diseases Bone Neoplasms Hematologic Diseases Bone neoplasms |
Neoplasm Metastasis Pain Bone Marrow Diseases Bone Diseases |
|
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |
