Radiotherapy and Chemotherapy in Advanced Non-Small Cell Lung Cancer

Closed for proposals

Project Type

Coordinated Research Project

Project Code

E33029

CRP

1465

Approved Date

2007/09/19

Status

4 - Closed

Start Date

2007/12/01

Expected End Date

2013/12/31

Completed Date

2013/10/10

Participating Countries

Canada
Chile
China
Croatia
Egypt
India
Malaysia
Malta
Morocco
Pakistan
Panama
Peru
South Africa
Tunisia

Description

Treatment of locally advanced and metastatic NSCLC is an important issue in radiation oncology worldwide, especially for low and middle income countries where up to 70-80% of all cancer patients are treated through palliative approach. In both locally advanced and metastatic NSCLC, palliation and quality of life are major goals of radiation therapy. By optimizing fractionation of radiotherapy and evaluating the role of chemotherapy in a resource sparing combined modality approach in NSCLC, it is expected that Member States will benefit from the rational use of existing equipment and staff levels, decreasing costs, yet providing optimal treatment for patients. It is also expected that this effort could lead to wide adoption of the resource sparing fractionation regimen in radiotherapy centres, promoting awareness of the necessity to perform shorter fractionation regimens and/or shorter chemotherapy regimens in this setting worldwide.

Objectives

The overall objective of the CRP is to optimize the treatment of locally
advanced and metastatic nonsmall cell lung cancer (NSCLC). This objective will
be achieved by
a) comparing survival after irradiation alone to that obtained with a combined
chemotherapy and radiotherapy in locally advanced NSCLC (Study A) and
b) by comparing chemotherapy alone to a combined radiotherapy and
chemotherapy in metastatic NSCLC (Study B).
These two questions refer not only to find out which is the optimal treatment,
but also have an implication in adequate use of resources. If there are not
significant differences, the assessment on QOL will be essential to define the
better option.

Specific objectives

To assess differences in quality of life (QOL) between the two regimens
investigated for both locally advanced and metastatic NSCLC (Study A and
Study B).

To compare a low-dose palliative thoracic radiotherapy of either 10 Gy in a
single fraction or 16 Gy in two fractions given with one week split against 2-3
cycles of chemotherapy, radiotherapy being followed by the same
chemotherapy in patients with metastatic NSCLC (Study B).

To compare toxicity between the two regimens investigated for both locally
advanced and metastatic NSCLC (Study A and Study B).

To study the efficacy of high-dose palliative thoracic radiotherapy of 39 Gy in
13 daily fractions compared to a 2-3 cycles of chemotherapy followed by a
low-dose palliative thoracic radiotherapy of either 10 Gy in a single fraction or
16 Gy in two fractions given with one week split in patients with locally
advanced NSCLC (Study A).

Impact

Adoption of the short RT schedule (study A) will result in efficient utilization of existing infrastructure which is relevant in MS with limited resources and with problems to RT access.

Relevance

Treatment of locally advanced and metastatic NSCLC is an important issue in radiation oncology worldwide, especially for low and middle income countries where up to 70-80% of all cancer patients are treated with palliative intent.

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