A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma
OBJECTIVES:
- Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB
non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy
comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical
resection for patients found to be resectable and consolidative chemotherapy comprising
paclitaxel and carboplatin.
- Determine the rate of complete pathological response in patients treated with this
regimen.
- Determine the feasibility of surgical resection after neoadjuvant induction
chemoradiotherapy in these patients.
- Determine disease-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Induction chemoradiotherapy: Patients undergo high-dose radiotherapy (including a total
of 6 fractions of boost radiotherapy after large field radiotherapy) once daily, 5 days
a week, for approximately 7 weeks. Beginning on the first day of radiotherapy, patients
also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly
for 6 weeks. Patients are reassessed 4 weeks after the completion of induction
chemoradiotherapy. Patients with resectable tumors undergo surgery within 2 weeks of
reassessment and then receive consolidation chemotherapy no later than 10 weeks after
surgery. Patients with unresectable tumors proceed directly to consolidation
chemotherapy.
- Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin
IV over 1 hour every 21 days for 2 courses.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2-3 years,
and then annually for 4-5 years.
PROJECTED ACCRUAL: A total of 21-60 patients will be accrued for this study within 20
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Stage IIIA (T1-3, N2) or IIIB (N3)
- No clinical or radiographic evidence of supraclavicular lymph node
involvement
- Pancoast tumors eligible
- Mediastinal nodal disease by mediastinoscopy, thoracoscopy, Chamberlain
procedure, or transbronchial needle aspirate
- Nodes found positive by mediastinoscopy are defined as N2 disease
- Primary tumor must be accessible for high-dose radiotherapy
- Measurable disease
- Potential candidate for surgery
- No small cell lung cancer
- No bronchoalveolar carcinoma with lobar or multilobar involvement
- No malignant pleural effusion
- No distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- At least 6 months
Hematopoietic
- White blood cell count (WBC) ≥ 3,000/mm^3
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
- Albumin ≥ 3.0 g/dL
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No clinically evident superior vena cava syndrome
Pulmonary
- Projected post-operative forced expiratory volume(FEV)_1 > 800 mL
Other
- No known hypersensitivity to Cremophor EL
- No unintentional weight loss ≥ 5% within the past 6 months
- No active serious infection
- No other serious medical condition that would preclude study participation
- No dementia or significantly altered mental status that would preclude giving
informed consent
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Concurrent steroids allowed as antiemetics or for prevention and amelioration of
hypersensitivity reactions
- No concurrent hormonal therapy (except megestrol for appetite stimulation, estrogen,
or birth control pills)
Radiotherapy
- No prior radiotherapy to the thorax
- No concurrent intensity-modulated radiotherapy
- No concurrent post-operative thoracic radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational therapy
- No concurrent amifostine
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mediastinal nodal sterilization rate
Outcome Time Frame:
At completion of concurrent chemotherapy and radiation therapy
Safety Issue:
No
Principal Investigator
Mohan Suntharalingam, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Maryland Greenebaum Cancer Center
Authority:
United States: Federal Government
Study ID:
RTOG-0229
NCT ID:
NCT00096226
Start Date:
September 2004
Completion Date:
Related Keywords:
- 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 |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| Tallahassee Memorial Hospital | Tallahassee, Florida 32308 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
| St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
