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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

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 - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Tallahassee Memorial HospitalTallahassee, Florida  32308
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103