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 - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003803

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	418
Study Start Date:	February 1999

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
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Amphia Ziekenhuis - locatie Molengracht
Breda, Netherlands, 4818 CK
Amphia Ziekenhuis
Breda, Netherlands, 4810 EV
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
Dr. Bernard Verbeeten Instituut
Tilburg, Netherlands, 5042 SB
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, Netherlands, 7334 DZ
Medisch Centrum Haaglanden
's-Gravenhage (Den Haag, The Hague), Netherlands, 2501 CK
Radiotherapeutisch Instituut-(Riso)
Deventer, Netherlands, 7400 AC
Reinier de Graaf Group
Delft, Netherlands, NL 2600 GA
Sophia Ziekehuis
Zwolle, Netherlands, 8000 GK
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, Netherlands, 5042 AD
United Kingdom, Scotland
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Study Chair:

Jose Belderbos, MD

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; on behalf of the EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. Epub 2006 Nov 3.

Study ID Numbers:	CDR0000066947, EORTC-08972
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003803 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses

Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009