Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Radiation: radiation; Other: Chemotherapy and radiotherapy; Drug: Chemotherapy; Other: Palliative radiotherapy and chemotherapy

• Registration Number: NCT00864331
• Lead Sponsor: International Atomic Energy Agency

Brief Summary

Primary objectives of the study are:

To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively

Secondary objectives are:

To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B

Detailed Description

To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic NSCLC (study B)

To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Histologically or cytologically confirmed NSCLC
• Stage IIIA/IIIB staged with
• CT chest and upper abdomen
• Liver, renal, hematological reserve appropriate (according to "standard" institutional values)
• Brain CT and/or bone scan only if clinical symptoms request such investigation
• Performance status KPS 60-90
• No second cancer except skin non-melanoma
• No previous treatment
• Patient must be contactable for follow-up
• Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
• Life expectancy > 3 months
• Patient must be able and willing to give informed consent, and fill in questionnaires

Study A

Exclusion Criteria

• Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified)
• RT field > 200 cm2
• Pregnancy

Study B Inclusion Criteria:

• KPS 60-90
• Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)
• Histologically or cytologically confirmed
• CT staged disease (thorax and possible upper abdomen)
• No second cancer except skin non-melanoma
• Liver, renal, haematological reserve appropriate (according to "standard" institutional values)
• No previous treatment
• Patient must be contactable for follow-up
• Patient must be able and willing to give informed consent and fill in questionnaires
• Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
• Life expectancy > 3 months

Study B Exclusion Criteria:

• Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)
• RT field > 200 cm2
• Pregnancy
• A-P separation too large to be adequately treated with 60-Co (?)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	radiation	For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
Chemotherapy and radiotherapy	Chemotherapy and radiotherapy	For patients in Group A (either stage IIIA or IIIB) receive a course of up to 3 cycles of chemotherapy followed by EBRT of 10 Gy in a single fraction or 16 Gy in 2 fractions 1 week apart.
Chemotherapy	Chemotherapy	For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
Palliative radiotherapy and chemotherapy	Palliative radiotherapy and chemotherapy	For patients in Group B (either stage IIIB (wet) or IV) receive EBRT of 10 Gy in a single fraction or 16 Gy in two fractions 1 week apart, followed by up to 3 cycles of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Survival	1 year

Secondary Outcome Measures

Name	Time	Method
To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B)	1 year
To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B	1 year

Trial Locations

Locations (13)

Tata Memorial Centre (TMC) Department of Atomic Energy (DAE); 🇮🇳 Mumbai, India

Misr Oncology Center (MOC); 🇪🇬 Cairo, Egypt

University of Zagreb Faculty of Medicine; 🇭🇷 Zagreb, Croatia

General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology; 🇲🇾 Kuala Lumpur, Malaysia

Instituto Oncológico National; 🇵🇦 Panama City, Panama

Institut de la Sante Publique, Institut National de Cancer Salah Azaiz; 🇹🇳 Tunis, Tunisia

University of Witwatersrand Johannesburg Hospital Dept of Radiation Oncology; 🇿🇦 Johannesburg, South Africa

Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology; 🇨🇳 Yinchuan, China

Instituto de Radiomedicine; 🇨🇱 Santiago, Chile

Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah; 🇲🇦 Rabat, Morocco

Sir Paul Boffa Hospital; 🇲🇹 Floriana, Malta

Nuclear Medicine Oncology and Radiotherapy Institute; 🇵🇰 Islamabad, Pakistan

Instituto Nacional de Enfermadades Neoplasicas Depto. De Radioterapia; 🇵🇪 Lima, Peru