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

Lung Cancer Clinical Trial

Official title:

Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00021112
• Other study ID #: EORTC-08981
• Secondary ID: EORTC-08981
• Status: Terminated
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: July 17, 2012
• Start date: April 2001

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• etoposide

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Germany	Thoraxklinik Rohrbach	Heidelberg
Netherlands	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
Poland	Medical University of Gdansk	Gdansk
Poland	National Institute of Tuberculosis and Lung Diseases	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Poland,