A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
18 Years
85 Years
Both
Non-small Cell Lung Cancer
Trial Information
A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both
local relapses and distant metastases are frequent, with 5-year survival of 3-17% for
inoperable disease. Staging has historically subdivided stage III disease into clinical
stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi
nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant
chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to
address optimal induction strategy.
Inclusion Criteria:
- Histopathologic diagnosis of non small-cell lung cancer
- Clinical stage IIIA and/or IIIB without pleural effusion
- ECOG functional status 0 or 1
- No renal function alteration (GFR >50%)
- No hepatic function alteration (ALT and AST less than 2 times its normal value)
- Leucocytes more than 2,000/mcl
- Hemoglobin more than 10mg/dL
- Platelets more than 100,000/mcl
Exclusion Criteria:
- Active uncontrolled infection.
- Serious concomitant disorders that would compromise the safety of patient or
compromise the patient's ability to tolerate therapy.
- MI within preceding 6 months or symptomatic heart disease including unstable angina,
congestive heart failure, or uncontrolled arrhythmia.
- Significant neurological or mental disorder.
- Second primary malignancy.
- Pregnant or nursing.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To estimate the time to recurrence
Outcome Time Frame:
Every 3 months
Safety Issue:
No
Principal Investigator
Jianxing He, MD, FACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
The First Affiliated Hospital of Guangzhou Medical University
Authority:
China: Food and Drug Administration
Study ID:
FAHG20070218
NCT ID:
NCT01054482
Start Date:
February 2007
Completion Date:
December 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Neoadjuvant chemotherapy
- neoadjuvant chemoradiotherapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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