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Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting


- 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


- 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



- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL


- 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


- FEV1 at least 800 mL


- 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


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- No prior pelvic or thoracic radiotherapy


- See Disease Characteristics


- Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed
provided cardiac conditions are stable

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Safety Issue:


Principal Investigator

Aruna J. Turaka, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




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



Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497