Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
18 Years
N/A
Both
Lung Cancer
Trial Information
Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
OBJECTIVES:
- Determine the complete resection rate and toxic death rate of patients with locally
advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and
radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
- Determine the survival, event-free survival, and incidence of pathologic complete
remission of patients treated with this regimen.
- Determine the protocol completion rate (CR) of patients treated with this regimen.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom
from distant metastasis rate, and freedom from local regional failure rate of patients
treated with this regimen.
OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6
weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22,
29, and 36.
Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients
with resectable disease undergo surgical resection within 4-8 weeks after induction therapy.
Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks
and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.
Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant
therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant
treatment repeats every 4 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed, newly diagnosed, unilateral primary
non-small cell lung cancer (NSCLC)
- Must have involvement of the superior sulcus, chest wall, or mediastinum
- Must have at least 1 of the following:
- Locally advanced Pancoast tumors with no documented mediastinal or
supraclavicular nodal involvement (T3-T4, N0-1)
- Resectable chest wall disease (T3, N0-1)
- Marginally resectable T4, N0-1, or NX central NSCLC
- N2 patients who are potentially resectable after induction chemoradiotherapy
- No evidence of extrathoracic spread to liver, adrenals, brain, or bone
- No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or
distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No superior vena cava syndrome
- No myocardial infarction within the past 6 months
- No active uncontrolled congestive heart failure
- No active uncontrolled arrhythmia within the past 6 months
Pulmonary
- FEV1 at least 800 mL
Other
- No other active invasive malignancy requiring therapy within the past 2 years
- No ongoing need for adjuvant therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months
after study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic or thoracic radiotherapy
Surgery
- See Disease Characteristics
Other
- Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed
provided cardiac conditions are stable
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Safety Issue:
Yes
Principal Investigator
Aruna J. Turaka, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000256334
NCT ID:
NCT00043108
Start Date:
July 2002
Completion Date:
Related Keywords:
- Lung Cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
