Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis

Closed for proposals

Project Type

Coordinated Research Project

Project Code

E33028

CRP

1432

Approved Date

23 April 2007

Status

Closed

Start Date

30 June 2007

Expected End Date

30 June 2013

Completed Date

16 July 2013

Description

Treatment of metastatic cancer (e.g. bone, lung, brain metastases) is an important aspect in radiation oncology worldwide, especially for developing countries where it is assumed that up to 70 % of all cancer patients are more suitable for palliative approach than for curative treatment. This is especially so in cases of bone metastases, where improving the access to and quality of care in pain relief are the major goals. Member states will benefit more for rational use of existing equipment and personnel allocations by optimising fractionation in palliative radiotherapy and by employing a single fraction treatment in palliation of bone metastases. This will decrease costs and provide optimal treatment by current standards for patient.

Objectives

To further optimize the dose fractionation treatment of painful bone metastases, for both single and multiple metastases, a prospective randomized trial is performed by comparing response to irradiation (pain relief) of two fractionation regimens for a single bone metastasis and two fractionation regimens for multiple bone metastases. Additionally, both quality of life and toxicity will be compared between the regimens used in single and multiple bone metastasis.

Specific objectives

1.To compare response rates (complete response, partial response, overall response) in patients with painful single bone metastasis treated with a single fraction radiotherapy (I) and to assess the differences in response rates (complete response, partial response, overall response) in patients with multiple bone metastasis treated with either a single fraction radiotherapy or fractionated radiotherapy in a phase III trial (II), as well as onset of response (pain relief) (III), and duration of response in responders (IV) in patients with either single (A) or multiple (B) bone metastasis.

2. To compare response rates (pain relief) of single fraction regimen (8 Gy) used in retreatments (re-irradiation) in patients with single bone metastasis (study A) and a single 8 Gy fraction in patients with multiple bone metastasis (study B) either relapsing after first response or in those not responding to the first/second irradiation.

3. To compare Quality of Life (QoL) and toxicity from the first irradiation (regardless of fractionation – single or two-fraction regimens) and those of the re-irradiation, including the rates of pathological fractures and spinal cord compression in the treatment fields between the two regimens tested in each group A and B, respectively.

Impact

Reinforcement of single dose (8Gy) RT protocol for treatment of painful bone metastases, which helps to deliver palliative care with efficient use of resources in all Member States.

Relevance

Radiotherapy for symptom control in patients with painful bone metastases is one of the most common indications for radiotherapy in all Member States.

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