Chemoradiotherapy of NSCLC Stage IIIB

NSCLC Stage IIIB Clinical Trial

Official title:

Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198432
• Other study ID #: IFCT-0201
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 9, 2016
• Start date: March 2002
• Est. completion date: December 2006

Study information

• Verified date: March 2016
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Concomitant Radiochemotherapy
• NSCLC Stage IIIB

Intervention

Drug:
• Paclitaxel, vinorelbine, cisplatin

Locations

Country	Name	City	State
France	CHU Saint-Etienne Pneumologie	Saint-Etienne

Sponsors (4)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique	Bristol-Myers Squibb, Ligue contre le cancer, France, Pierre Fabre Laboratories

Country where clinical trial is conducted

France, 

References & Publications (1)

Fournel P, Vergnenégre A, Robinet G, Léna H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daurès JP, Chouaid C, Martel-Lafay I; GFPC and IFCT team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung can — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate
Secondary	Overall survival
Secondary	Time to progression
Secondary	Relapse rate (local control)
Secondary	Safety