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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
etoposide
conventional surgery
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • Universitair Ziekenhuis Antwerpen
  • Thoraxklinik Rohrbach
  • Gelre Ziekenhuizen - Lokatie Lukas
  • Sint Antonius Ziekenhuis
  • Rotterdam Cancer Institute
  • University Hospital - Rotterdam Dijkzigt
  • Academisch Ziekenhuis Utrecht
  • Medical University of Gdansk
  • National Institute of Tuberculosis and Lung Diseases

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00021112
Brief Title
Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Official Title
Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
April 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Van Klaveren, MD, PhD
Organizational Affiliation
University Medical Center Rotterdam at Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Thoraxklinik Rohrbach
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Gelre Ziekenhuizen - Lokatie Lukas
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
University Hospital - Rotterdam Dijkzigt
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
National Institute of Tuberculosis and Lung Diseases
City
Warsaw
Country
Poland

12. IPD Sharing Statement

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

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