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A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III


OBJECTIVES:

- Compare survival, disease-free survival, local control, and pattern of recurrence in
patients with unresectable stage I, II, or low-volume stage III non-small lung cancer
treated with high-dose radiotherapy either preceded by induction chemotherapy with
gemcitabine and cisplatin or combined with daily cisplatin.

- Compare the acute and late toxic effects of these regimens in these patients.

- Determine the quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to
one of two treatment arms.

- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV
over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo
high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a
week, for 24 fractions, using a concurrent boost technique up to 66 Gy.

- Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose
accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24
fractions, using a concurrent boost technique up to 66 Gy.

Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35.

Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study
within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Stage I, II, III (T1-4, N0-3, M0)

- No metastases to supraclavicular, contralateral hilar, or contralateral
scalene lymph nodes

- Medically inoperable or unresectable

- No pleural or pericardial effusion (except with repeated negative cytology)

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0 or 1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

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

- Hemoglobin at least 6.8 g/dL

- No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 1.25 times normal OR

- Creatinine clearance greater than 70 mL/min

Cardiovascular:

- No evidence of heart failure

- No myocardial infarction within the past 6 months

- No superior vena cava syndrome

Pulmonary:

- FEV1 at least 1 L

- No pre-existing fibrotic lung disease

- No postobstructive pneumonia preventing exact delineation of tumor volume

- Diffusion capacity at least 60%

Other:

- No weight loss of more than 10% in the past 3 months

- No uncontrolled infection

- No serious medical risk factors involving any of the major organ systems that would
preclude adherence to the study treatment schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to the chest

- Maximum length of the esophagus receiving 40 Gy no greater than 18 cm

- Maximum length of the esophagus receiving 66 Gy no greater than 12 cm

- Must limit the spinal cord dose to a maximum of 50 Gy

- Must be able to exclude 25% of the heart from the boost volume

Surgery:

- Not specified

Other:

- No other concurrent experimental medications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jose Belderbos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

United States: Federal Government

Study ID:

EORTC-08972-22973

NCT ID:

NCT00003803

Start Date:

February 1999

Completion Date:

Related Keywords:

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

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