EUCTR2013-001494-24-FR
Active, not recruiting
Phase 1
A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay - 14-GENE
IFCT0 sites1,050 target enrollmentDecember 18, 2013
ConditionsCompletely resected stage I or IIA non-squamous non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10029517Term: Non-small cell lung cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029518Term: Non-small cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Completely resected stage I or IIA non-squamous non-small cell lung cancer (NSCLC)
- Sponsor
- IFCT
- Enrollment
- 1050
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent
- •2\. Age \= 18 years
- •3\. Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy and likely compliance with follow\-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).
- •4\. Histologically documented completely resected (R0\) Stage I or IIA non\-squamous NSCLC (per 8th edition, TNM staging system)
- •5\. Adequate tissue sample for the 14\-Gene Prognostic Assay
- •6\. Life expectancy excluding NSCLC diagnosis \= 5 years
- •7\. ECOG performance status 0\-1
- •8\. Adequate haematological function:
- •Absolute neutrophil count (ANC) \= 1500 cells/mm3 AND
- •Platelet count \= 100000 cells/mm3 AND
Exclusion Criteria
- •1\. Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histologies
- •2\. Evidence of greater than stage IIA pathologic staging
- •3\. Evidence of incomplete resection
- •4\. Pregnant or lactating women
- •5\. Unwilling to use an effective means of contraception
- •6\. Active infection, either systemic or at site of primary resection
- •7\. Systemic chemotherapy or anti\-cancer agent within 5 years prior to enrollment
- •8\. Any pre\- or post\-operative radiotherapy
- •9\. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically, ductal carcinoma in situ treated surgically
- •10\. Treatment with any investigational drug or participation in another clinical trial within 28 days prior to enrollment
Outcomes
Primary Outcomes
Not specified
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