Adjuvant Chemotherapy in Patients With High Risk Stage I Non-squamous Non-Small Cell Lung Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | May 2013 |
| Contact: | Michael Mann, MD |
| Phone: | (650) 557-4916 |
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
The optimal treatment for stage I non-small cell lung cancer (NSCLC) remains controversial.
Radiographic surveillance alone has been recommended for stage I 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 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 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 NSCLC patients at high risk of death within five
years after operation. A new prognostic tool, the Pervenio™ Lung RS Assay, which has been
validated and definitively demonstrated in large scale studies to identify high-risk stage I
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.
Radiographic surveillance alone has been recommended for stage I 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 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 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 NSCLC patients at high risk of death within five
years after operation. A new prognostic tool, the Pervenio™ Lung RS Assay, which has been
validated and definitively demonstrated in large scale studies to identify high-risk stage I
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.
Inclusion Criteria:
- Written informed consent
- Age ≥ 18 years
- Adequate tissue sample for Pervenio™ testing
- Histologically documented completely resected (R0) Stage I non-squamous NSCLC
- Life expectancy excluding NSCLC diagnosis ≥ 5 years
- ECOG performance status 0-1
- Adequate haematological function:
1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND
2. Platelet count ≥ 100000 cells/mm3 AND
3. Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level)
- Adequate liver function:
1. Total bilirubin < 1.5 x upper limit of normal (ULN) AND
2. 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 Criteria:
- Final pathologic diagnosis of squamous cell histology
- Evidence of greater than stage I 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
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