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Razor-Encore - 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 Intermediate or High Risk by a 14-Gene Prognostic AssayThe optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.
Learn more at clinicaltrials.govInclusion
- Written informed consent
- Age ≥ 18 years
- Adequate tissue sample for the 14-Gene Prognostic Assay
- Histologically documented completely resected (R0) Stage I or Stage IIA non-squamous NSCLC
- Life expectancy excluding NSCLC diagnosis ≥ 5 years
- ECOG performance status 0-1
- Adequate haematological function:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND
- Platelet count ≥ 100000 cells/mm3 AND
- Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level)
- Adequate liver function:
- Total bilirubin < 1.5 x upper limit of normal (ULN) AND
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- Adequate renal function, with Serum creatinine ≤ 1.5 x ULN
- Completely healed incisions
Exclusion
- Final pathologic diagnosis of purse squamous cell histology, pure small cell or pure neuroendocrine histology, or any combination of only these three histologies.
- Evidence of greater than stage II A pathologic staging
- Evidence of incomplete resection
- Pregnant or lactating women
- Unwilling to use an effective means of contraception
- Active infection, either systemic or at site of primary resection
- Prior systemic chemotherapy or anti-cancer agent
- Any pre- or post-operative radiotherapy
- 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
- Treatment with any investigational drug or participation in another clinical trial within 28 days prior to enrollment
- Known hypersensitivity to any of the study treatment agents
- Evidence of any other disease including infection that contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment related complications