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Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy


Phase 2
18 Years
75 Years
Not Enrolling
Both
Lung Cancer

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Trial Information

Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy


OBJECTIVES:

- Determine the incidence of radically resected disease in patients with stage IIIB
non-small cell lung cancer treated with induction cisplatin, etoposide, and
radiotherapy followed by surgical resection.

- Determine the toxicity (morbidity and mortality) of this regimen in these patients.

- Determine the clinical response rate and pathological response rate in patients treated
with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on
days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second
course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for
5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable
toxicity.

At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo
lobectomy or pneumonectomy.

Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually
thereafter.

PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary stage IIIB non-small cell lung
cancer (NSCLC)

- T4, any N, M0 or any T, N3, M0

- No N3 disease due to scalene or supraclavicular lymph node involvement

- No primary tumors located in the lower lobe combined with contralateral upper higher
mediastinal lymph node involvement

- No mixed tumor types with small cell lung cancer

- At least 1 unidimensionally measurable target lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- No pre-existing pleural or pericardial effusion

- No CNS involvement by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- WHO 0-1

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 times upper limit of normal (ULN)

- AST/ALT no greater than 1.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.25 times ULN

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No clinical evidence of superior vena cava syndrome

Pulmonary:

- Postoperative FEV1 and KCO greater than 40% predicted

- VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40%
predicted)

Other:

- No other primary malignancy except carcinoma in situ of the cervix, adequately
treated basal cell skin cancer, or other malignancy treated more than 5 years ago
without recurrence (excluding melanoma, breast cancer, or hypernephroma)

- No active uncontrolled infection requiring IV antibiotics

- No pre-existing sensory neurotoxicity grade 2 or greater

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy for NSCLC

- No concurrent immunotherapy during induction chemoradiotherapy

- Concurrent colony stimulating factors allowed

Chemotherapy:

- No prior chemotherapy for NSCLC

Endocrine therapy:

- No concurrent anticancer hormonal agents (except corticosteroids for antiemetic
prophylaxis) during induction chemoradiotherapy

Radiotherapy:

- No prior radiotherapy for NSCLC

Surgery:

- No prior surgery for NSCLC

Other:

- No other concurrent anticancer drugs during induction chemoradiotherapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Rob Van Klaveren, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Medical Center Rotterdam at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-08981

NCT ID:

NCT00021112

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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