Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

NCT ID: NCT00021112

Last Updated: 2012-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

Brief Summary

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 may kill more tumor cells.

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

Detailed Description

OBJECTIVES:

• Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
• Determine the toxicity (morbidity and mortality) of this regimen in these patients.
• Determine the clinical response rate and pathological response rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.

At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.

Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)

• T4, any N, M0 or any T, N3, M0
• No N3 disease due to scalene or supraclavicular lymph node involvement
• No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement
• No mixed tumor types with small cell lung cancer
• At least 1 unidimensionally measurable target lesion

• At least 20 mm by conventional techniques OR
• At least 10 mm by spiral CT scan
• No pre-existing pleural or pericardial effusion
• No CNS involvement by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3
• Platelet count at least 100,000/mm ^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 1.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.25 times ULN
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No clinical evidence of superior vena cava syndrome

Pulmonary:

• Postoperative FEV1 and KCO greater than 40% predicted
• VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)

Other:

• No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma)
• No active uncontrolled infection requiring IV antibiotics
• No pre-existing sensory neurotoxicity grade 2 or greater
• No psychological, familial, sociological, or geographical condition that would preclude study compliance
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for NSCLC
• No concurrent immunotherapy during induction chemoradiotherapy
• Concurrent colony stimulating factors allowed

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• No prior surgery for NSCLC

Other:

• No other concurrent anticancer drugs during induction chemoradiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rob Van Klaveren, MD, PhD

Role: STUDY_CHAIR

University Medical Center Rotterdam at Erasmus Medical Center

Locations

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Thoraxklinik Rohrbach

Heidelberg, , Germany

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Rotterdam Cancer Institute

Rotterdam, , Netherlands

University Hospital - Rotterdam Dijkzigt

Rotterdam, , Netherlands

Academisch Ziekenhuis Utrecht

Utrecht, , Netherlands

Medical University of Gdansk

Gdansk, , Poland

National Institute of Tuberculosis and Lung Diseases

Warsaw, , Poland

Countries

Belgium; Germany; Netherlands; Poland

Other Identifiers

EORTC-08981

Identifier Type: -

Identifier Source: secondary_id

EORTC-08981

Identifier Type: -

Identifier Source: org_study_id