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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


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

Thank you

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 InstitutePittsburgh, Pennsylvania  15213
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Overlook HospitalSummit, New Jersey  07902-0220