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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
Not Enrolling
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


- 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

- 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

- 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

Inclusion Criteria


- 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

- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- At least 6 months


- White blood cell count (WBC) ≥ 3,000/mm^3

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- 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


- Creatinine ≤ 1.5 times ULN


- No clinically evident superior vena cava syndrome


- Projected post-operative forced expiratory volume(FEV)_1 > 800 mL


- 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


Biologic therapy

- Not specified


- 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)


- No prior radiotherapy to the thorax

- No concurrent intensity-modulated radiotherapy

- No concurrent post-operative thoracic radiotherapy


- Not specified


- No other concurrent investigational therapy

- No concurrent amifostine

Type of Study:


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:


Principal Investigator

Mohan Suntharalingam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Federal Government

Study ID:




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



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