Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

Swiss Group for Clinical Cancer Research

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Procedure: conventional surgery; Radiation: Hyperfractionated; Drug: Taxotere/Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00030810

EU-20137

SAKK 16/01

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Full description

OBJECTIVES:

• 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 regimen.
• Determine the operability and complete resection rate in patients treated with this regimen.
• 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• 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

Renal:

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• 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

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• 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)

Radiotherapy:

• No prior radiotherapy to the chest

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since prior treatment in a clinical trial
• No prior cytostatic therapy
• No other concurrent experimental drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)