EUCTR2013-001494-24-ES
Active, not recruiting
Not Applicable
A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio? Lung RS Assay
Encore Clinical, Inc0 sites1,050 target enrollmentSeptember 16, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Completely resected stage I non-squamous non-small cell lung cancer (NSCLC)
- Sponsor
- Encore Clinical, Inc
- Enrollment
- 1050
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent (the informed consent document must have been approved by the appropriate Institutional Review Board/Independent Ethics Committee (IRB/IEC). Consent
- •must be obtained and signed and witnessed PRIOR to any study specific activity.
- •2\. Age ? 18 years
- •3\. Able to comply with the protocol, including follow\-up especially for anticipated length of study (i.e. 5 years from the initiation of enrollment).
- •4\. Histologically documented completely resected (R0\) Stage I non\-squamous NSCLC. Eligible resections include lobectomy, bi\-lobectomy, sleeve lobectomy and pneumonectomy.
- •Resections via segmentectomy or wedge resection will not be eligible. Complete resection must also be accompanied, at a minimum, by intra\-operative systematic mediastinal lymph
- •node sampling. Systematic sampling is defined as removal of at least one representative lymph node each from levels 4 and 7 for a right\-sided cancer and from levels 5 and/or 6 and 7 for left\-sided cancers. Complete mediastinal lymph node dissection (MLND), however, is preferred, and is defined as resection of all lymph nodes at those same levels for right\- and
- •left\-sided cancers.
- •5\. Adequate tissue sample available for Pervenio testing (paraffin block with tumor occupying at least 25% of the tissue surface area)
- •6\. Life expectancy excluding NSCLC diagnosis ? 5 years
Exclusion Criteria
- •1\. Final pathologic diagnosis on resected specimen is squamous cell histology
- •2\. Evidence of greater than stage I pathologic staging, including loco\-regional regional (hilar) or mediastinal lymph node involvement or nodal enlargement that has not been biopsied, or
- •of distant metastatic disease (lesions that have been biopsy\-proven or that are suspicious on brain MRI and/or PET scan)
- •3\. Evidence of incomplete resection, including positive resection margins, additional suspect nodules
- •4\. Pregnant or lactating women
- •5\. Women with an intact uterus (unless amenorrhoeic for the previous 24 months) unwilling to use an effective means of contraception (including oral contraceptive, intrauterine
- •contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last
- •administration of study chemotherapy. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of study chemotherapy.
- •6\. Active infection, either systemic or at site of primary resection
- •7\. Any pre\-operative systemic chemotherapy or treatment with an anti\-cancer agent
Outcomes
Primary Outcomes
Not specified
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