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Completed

NCT Number: NCT00198432

Chemoradiotherapy of NSCLC Stage IIIB

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.

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Key information

Conditions

NSCLC Stage IIIB Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Concomitant Radiochemotherapy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Saint-Etienne Pneumologie

Saint-Etienne, 42000, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel, vinorelbine, cisplatin

Drug

Primary outcomes

  1. Objective response rate

Secondary outcomes

  1. Overall survival

  2. Time to progression

  3. Relapse rate (local control)

  4. Safety

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • Bristol-Myers Squibb
  • Ligue contre le cancer, France
  • Pierre Fabre Laboratories

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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