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

International Atomic Energy Agency

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Chemotherapy; Radiation: radiation; Other: Palliative radiotherapy and chemotherapy; Other: Chemotherapy and radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00864331

E33029

Details and patient eligibility

About

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

Full 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

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Study A 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 (?)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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251 participants in 4 patient groups

Radiotherapy

Active Comparator group

Description:

For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.

Treatment:

Radiation: radiation

Chemotherapy and radiotherapy

Experimental group

Description:

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.

Treatment:

Other: Chemotherapy and radiotherapy

Chemotherapy

Active Comparator group

Description:

For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.

Treatment:

Drug: Chemotherapy

Palliative radiotherapy and chemotherapy

Experimental group

Description:

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.

Treatment:

Other: Palliative radiotherapy and chemotherapy