Clinical trial NCT00004253: Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-07-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
Study officials:
affiliation: Baptist Health South Florida
name: Andre A. Abitbol, MD
role: STUDY_CHAIR
References: