A Phase III Trial of Induction Paclitaxel and Carboplatin Followed By Standard Radiotherapy (64 Gy/7 Weeks) vs. Hyperfractionated Accelerated Radiotherapy (HART 57.6 Gy/2.5 Weeks) For Patients With Unresectable Stage IIIA and IIIB Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase III Trial of Induction Paclitaxel and Carboplatin Followed By Standard Radiotherapy (64 Gy/7 Weeks) vs. Hyperfractionated Accelerated Radiotherapy (HART 57.6 Gy/2.5 Weeks) For Patients With Unresectable Stage IIIA and IIIB Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine response rates, duration of response, and survival of patients with
unresectable or regionally advanced (M0) stage IIIA or IIIB non-small cell lung carcinoma
treated with induction paclitaxel and carboplatin followed by conventional vs accelerated
radiation. II. Evaluate the patterns of local and distant failure for patients treated with
these regimens.
OUTLINE: Patients are stratified by histology (squamous vs nonsquamous), performance status
(0 vs 1), disease stage (IIIA vs IIIB), and response to induction chemotherapy (initial
response vs no response). All patients receive induction therapy consisting of paclitaxel IV
over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats
every 42 days for 2 courses. Patients whose disease has not progressed outside the thorax
are then randomized to 1 of 2 treatment arms. Arm I: Patients receive standard radiotherapy
once a day, 5 days a week for 6-7 weeks. Arm II: Patients receive hyperfractionated
accelerated radiotherapy 3 times daily, 5 days a week over 2.5 weeks. Each fraction is
separated by a minimum of 4 hours. Radiotherapy begins between days 43 and 50. Patients are
followed at 1 month after radiotherapy, then every 3 months for 2 years, every 6 months for
the next 3 years, and annually thereafter.
PROJECTED ACCRUAL: Approximately 294 patients will be accrued for this study within 3.5
years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage IIIA or IIIB
non-small cell carcinoma of the lung Adenocarcinoma Squamous cell carcinoma Anaplastic
large cell carcinoma Stage IIIA patients must not be candidates for resection after
neoadjuvant therapy (unresectable T3N1 or T1-3 primary tumors with metastasis limited to
the ipsilateral mediastinal and subcarinal lymph nodes) Mediastinotomy or thoracoscopy
required for potentially resectable IIIa disease when ipsilateral mediastinal lymph nodes
are less than 2 cm Stage IIIB patients must not have significant pleural effusion (seen on
CT scan only OR does not reaccumulate after one thoracentesis and is cytologically
negative) Metastases to contralateral mediastinal or supraclavicular nodes allowed
Measurable or evaluable disease No distant metastasis or significant pleural effusion
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less
than 1.5 mg/dL SGOT no greater than 2 times normal No liver disease with significant
hepatic insufficiency Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance
at least 50 mL/min Cardiovascular: No cardiac arrhythmia or end stage congestive heart
failure Neurologic: No preexisting clinically significant peripheral neuropathy No organic
brain syndrome Other: No history of prior or concurrent malignancy in the past 5 years
except: Surgically cured basal cell carcinoma of the skin Carcinoma in situ of the cervix
Not pregnant Fertile patients must use effective contraception during and for 2 weeks
after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy
Surgery: Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Chandra P. Belani, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000066107
NCT ID:
NCT00003235
Start Date:
April 1998
Completion Date:
Related Keywords:
- Lung Cancer
- squamous cell lung cancer
- large cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- adenocarcinoma of the lung
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Community Medical Center | Toms River, New Jersey 08755 |
| St. Francis Medical Center | Trenton, New Jersey 08629 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
| Overlook Hospital | Summit, New Jersey 07902-0220 |
