Optimization of Radiotherapy in Treatment of Painful Bone Metastasis (bone mets)
This study is currently recruiting participants.
Verified October 2011 by International Atomic Energy Agency
Sponsor:
International Atomic Energy Agency
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00610272
First received: January 25, 2008
Last updated: October 12, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 metastasis 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis |
Resource links provided by NLM:
Further study details as provided by International Atomic Energy Agency:
Primary Outcome Measures:
- Pain Relief (response rate) at 4 weeks [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Onset and Duration of Pain Relief in Responders [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
- Rates of Pathological Fractures and Spinal Cord Compression [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Site Radiation 4Gy Fraction
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 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
|
|
Active Comparator: Single Site Radiation 8Gy Fraction
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
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
|
|
Active Comparator: Multiple Sites Radiation 8Gy Fraction
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
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);
|
|
Experimental: Multiple Sites Radiation 12Gy Fraction
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
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) ;
|
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- histological diagnosis of malignancy associated with radiological evidence of painful bone metastasis
- If patients with two sites of pain requiring separate treatment are to be entered, the same randomized treatment option will be used for both sites, but response at each site will be scored and analyzed separately.
- age > 18 years
- anticipated remaining life of at least 12 weeks (3 months)
- informed consent
Exclusion Criteria:
- Primary histology myeloma
- Sites of previous RT or previous radioisotope treatment
- conditions or circumstances, which may interfere with treatment or follow-up
- complicated bone metastasis (pathological fractures, metastatic spinal cord compression)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610272
Contacts
| Contact: Branislav Jeremic, MD, PhD | +4312600 ext 21666 | b.jeremic@iaea.org |
| Contact: Chandra Soysa | +4312600 ext 21656 | C.Soysa@iaea.org |
Locations
| Algeria | |
| Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU) | Recruiting |
| Alger, Algeria, 16016 | |
| Principal Investigator: Seam Oukrif Epse Ould Ali | |
| Brazil | |
| Irmandade de Santa Casa de Misericordia de Porto Alegre | Recruiting |
| Porto Alegre, Brazil, 90020-090 | |
| Principal Investigator: Gunther Schneider | |
| Egypt | |
| Misr Oncology Center (MOC) | Recruiting |
| Cairo, Egypt | |
| Contact: Sherif Abdelwahab | |
| Principal Investigator: Sherif Abdel Wahab | |
| India | |
| Tata Memorial Hospital | Recruiting |
| Mumbai, India, Maharashtra 400 012 | |
| Contact: Rakesh Jalali | |
| Principal Investigator: Rakseh Jalali | |
| Lithuania | |
| Institute of Oncology, University of Vilinius | Recruiting |
| Vilnius, Lithuania, 08660 | |
| Contact: Arvydas BURNECKIS | |
| Principal Investigator: Arvydas BURNECKIS | |
| Macedonia, The Former Yugoslav Republic of | |
| Institute of Radiotherapy and Oncology | Recruiting |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Principal Investigator: Oliver Arsovski | |
| Mexico | |
| Instituto Nacional de Cancerología (INCAN) | Recruiting |
| Ciudad de Mexico, Mexico, 14080 | |
| Principal Investigator: Catalina Tenorio Tellez | |
| Serbia | |
| Institute of Oncology and Radiology | Recruiting |
| Belgrade, Serbia, 11000 | |
| Principal Investigator: Nenad Borojevic | |
| Spain | |
| Hospital Clinic Universidad de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Francesc Casas, MD FCASAS@clinic.ub.es | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Spain, 07014 | |
| Principal Investigator: Ana Ma. Mena | |
| Tunisia | |
| Institut national de cancer Salah Azaiz | Recruiting |
| Tunis, Tunisia, Bab Saadoun 1006 | |
| Principal Investigator: Lotfi Kochbati | |
| United Kingdom | |
| Mount Vernon Cancer Centre | Recruiting |
| Northwood, United Kingdom, HA6 2 RN | |
| Principal Investigator: Peter John Hoskin | |
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
| Study Chair: | Branislav Jeremic, Md, PhD | International Atomic Energy Agency |
More Information
Additional Information:
Publications:
| Responsible Party: | International Atomic Energy Agency |
| ClinicalTrials.gov Identifier: | NCT00610272 History of Changes |
| Other Study ID Numbers: | E33028 |
| Study First Received: | January 25, 2008 |
| Last Updated: | October 12, 2011 |
| Health Authority: | United Nations: International Atomic Energy Agency |
Keywords provided by International Atomic Energy Agency:
|
single bone metastasis multiple bone metastasis pain relief radiotherapy |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms |
Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013