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OpenTrials
Completed

NCT Number: NCT00198354

Stage I/II NSCLC Perioperative Chemotherapy

The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.

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Key information

Conditions

Non-small Cell Lung Cancer Stage I and II Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Peri-operative Chemotherapy Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Besancon - Pneumologie

Besançon, 25000, France

About this study

In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

Exclusion criteria

NSCLC stage III or IV

Treatment and study plan

gemcitabine + cisplatine

Drug

gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)

paclitaxel + carboplatine

Drug

paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)

Primary outcomes

  1. Compare 3-Years survival

    Time frame: 3 years

Secondary outcomes

  1. Compare Objective response rate

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Registry information

Official study title

Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC

Important dates

Study start
2001
Primary completion
2009
Study completion
2010
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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