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A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin


OBJECTIVES:

- Determine the probability of overall survival and local control in patients with
favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving
paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy
(3D-CHRT).

- Determine the incidence and severity of nonhematologic toxicity, specifically
esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and
carboplatin in these patients.

- Correlate complication rate with radiation based on the effective dose to determine
safe treatment guidelines.

- Determine the feasibility of patient-specific dose escalation using this regimen in
these patients.

- Determine the quality of life and symptom distress in these patients on this regimen.

OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy
(3D-CHRT).

Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30
minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8
weeks.

Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels.

Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and
at 3 and 6 months.

Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and
then annually thereafter.

PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patients with unresected locally advanced non-small cell lung cancer

- Stage II, IIIA, or IIIB

- No evidence of hematogenous metastases

- No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive
thoracic procedure)

- No intrathoracic tumor recurrence following resection

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute granulocyte count at least 2,000/mm3

- Platelet count at least 130,000/mm3

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 1.5 times upper limit of normal (unless caused by documented
benign disease)

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No active or symptomatic cardiac disease

- No acute myocardial infarction within the past 6 months

- No angina

- No congestive heart failure

- No uncontrolled arrhythmias

- Cardiac ejection fraction greater than 50%

Pulmonary:

- FEV1 at least 1.25 L AND

- DLCO at least 50% predicted

Other:

- Not pregnant

- Fertile patients must use effective contraception

- Weight loss no greater than 5% within 3 months of diagnosis

- No other prior malignancy within the past 3 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior thoracic or neck radiotherapy

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Andre A. Abitbol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baptist Health South Florida

Authority:

United States: Federal Government

Study ID:

CDR0000067500

NCT ID:

NCT00004253

Start Date:

March 2000

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

Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Baptist Hospital of MiamiMiami, Florida  33176-2197