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Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

Phase 2
18 Years
75 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial


- Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin,
and radiotherapy followed by surgery in patients with operable stage IIIB non-small
cell lung cancer.

- Determine the rate of event-free survival at 1 year in patients treated with this

- Determine the operability and complete resection rate in patients treated with this

- Determine the postoperative 30-day mortality in patients treated with this regimen.

- Determine the response rate, failure pattern, and overall survival in patients treated
with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment
repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease
receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed, operable stage IIIB non-small cell lung cancer

- T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for
assessment of N3 disease) or CT scan or MRI of the thorax

- Squamous cell

- Adenosquamous cell

- Large cell

- Poorly differentiated

- No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan,
and abdominal ultrasound or CT scan

- No malignant pleural or pericardial effusion

- No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes



- 18 to 75

Performance status:

- WHO 0-1

Life expectancy:

- Not specified


- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- AST and/or ALT no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN


- Creatinine clearance at least 60 mL/min


- No unstable cardiac disease requiring treatment

- No congestive heart failure

- No angina pectoris (even if medically controlled)

- No significant arrhythmia

- No myocardial infarction within the past 3 months


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No definite contraindications for the use of corticosteroids as premedication

- No preexisting grade 2 or greater peripheral neuropathy

- No active uncontrolled infection

- No uncontrolled diabetes mellitus

- No other prior or concurrent malignancy except non-melanomatous skin cancer or
adequately treated carcinoma in situ of the cervix

- No prior significant neurologic or psychiatric disorders including psychotic
disorders, dementia, or seizures that would preclude informed consent

- No other serious underlying medical condition that would preclude study participation

- No socioeconomic or geographical circumstances that would preclude study compliance


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- No concurrent corticosteroids except as prophylactic pretreatment medication,
treatment for acute hypersensitivity reactions, or chronic treatment (initiated more
than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)


- No prior radiotherapy to the chest


- See Disease Characteristics


- At least 30 days since prior treatment in a clinical trial

- No prior cytostatic therapy

- No other concurrent experimental drugs

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of event-free survival measured 1 year after registration

Safety Issue:


Principal Investigator

Roger Stupp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois


Switzerland: Swissmedic

Study ID:

SAKK 16/01



Start Date:

September 2001

Completion Date:

May 2006

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenosquamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms