Chemoradiotherapy of NSCLC Stage IIIB

Intergroupe Francophone de Cancerologie Thoracique

Status and phase: Completed; Phase 2

Conditions: Concomitant Radiochemotherapy; NSCLC Stage IIIB

Treatments: Drug: Paclitaxel, vinorelbine, cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00198432

IFCT-0201

Details and patient eligibility

About

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

Full description

Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
• PS = 0 or 1
• Possibility of including all the targets in only one exposure field
• Slimming < 10% of the weight of the body
• Functions hepatic, renal and hematologic normal
• VEMS >40% and PaO2 >60 mmHg
• written and signed informed consent

Exclusion criteria :

• NSCLC stage IV or wet-IIIB

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)