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Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).


Inclusion Criteria:



- NSCLC that is defined as other than predominantly squamous cell histology (squamous
cell and/or mixed small cell, non-small cell histology is not permitted)

- Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM
classification 2008)

- Performance status (PS) = 0 or 1

- 18 years <= age < 70 years

- Signed inform consent

Exclusion Criteria:

- Squamous cell carcinoma

- Previous cancer excepted those treated for more than 5 years and considered cured,
basocellular skin carcinoma, carcinoma in situ of uterine cervix

- Inadequate renal or cardiac functions

- Pregnant women

- Any of the following within 6 months prior to study enrollment: myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
NYHA class III or IV congestive heart failure, cerebrovascular accident or transient
ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive
esophagitis or gastritis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)

Outcome Time Frame:

week

Safety Issue:

Yes

Principal Investigator

Jean-Charles SORIA, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Gustave Roussy (IGR)

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IFCT-0801

NCT ID:

NCT00775385

Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Chemotherapy, Adjuvant
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

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