Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003803
First received: November 1, 1999
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 158
Study Start Date: February 1999
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin.
  • Compare the acute and late toxic effects of these regimens in these patients.
  • Determine the quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.
  • Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.

Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35.

Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Stage I, II, III (T1-4, N0-3, M0)

      • No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes
    • Medically inoperable or unresectable
  • No pleural or pericardial effusion (except with repeated negative cytology)

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 6.8 g/dL
  • No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 1.25 times normal OR
  • Creatinine clearance greater than 70 mL/min

Cardiovascular:

  • No evidence of heart failure
  • No myocardial infarction within the past 6 months
  • No superior vena cava syndrome

Pulmonary:

  • FEV1 at least 1 L
  • No pre-existing fibrotic lung disease
  • No postobstructive pneumonia preventing exact delineation of tumor volume
  • Diffusion capacity at least 60%

Other:

  • No weight loss of more than 10% in the past 3 months
  • No uncontrolled infection
  • No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the chest
  • Maximum length of the esophagus receiving 40 Gy no greater than 18 cm
  • Maximum length of the esophagus receiving 66 Gy no greater than 12 cm
  • Must limit the spinal cord dose to a maximum of 50 Gy
  • Must be able to exclude 25% of the heart from the boost volume

Surgery:

  • Not specified

Other:

  • No other concurrent experimental medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003803

Locations
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
France
CHR de Grenoble - La Tronche
Grenoble, France, 38043
Germany
Mutterhaus der Borromaerinnen
Trier, Germany, D-54219
Netherlands
Medisch Centrum Haaglanden
's-Gravenhage (Den Haag, The Hague), Netherlands, 2501 CK
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, Netherlands, 7334 DZ
Amphia Ziekenhuis - locatie Molengracht
Breda, Netherlands, 4818 CK
Amphia Ziekenhuis
Breda, Netherlands, 4810 EV
Reinier de Graaf Group
Delft, Netherlands, NL 2600 GA
Radiotherapeutisch Instituut-(Riso)
Deventer, Netherlands, 7400 AC
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, Netherlands, 5042 AD
Dr. Bernard Verbeeten Instituut
Tilburg, Netherlands, 5042 SB
Sophia Ziekehuis
Zwolle, Netherlands, 8000 GK
United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Jose Belderbos, MD The Netherlands Cancer Institute
  More Information

Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003803     History of Changes
Other Study ID Numbers: EORTC-08972-22973, EORTC-08972
Study First Received: November 1, 1999
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage III non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014