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

NCT00003803 | Terminated Phase 3

• 2 other identifiers: EORTC-08972-22973EORTC-08972
• Study Type: interventional
• Target: 158
• Locations: 5 countries
• Sites: 17

Brief Summary

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage III non-small cell lung cancer

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (17)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Mutterhaus der Borromaerinnen

Trier, D-54219, Germany

Location

Medisch Centrum Haaglanden

's-Gravenhage (Den Haag, the Hague), 2501 CK, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, 7334 DZ, Netherlands

Location

Amphia Ziekenhuis

Breda, 4810 EV, Netherlands

Location

Amphia Ziekenhuis - locatie Molengracht

Breda, 4818 CK, Netherlands

Location

Reinier de Graaf Group

Delft, NL 2600 GA, Netherlands

Location

Radiotherapeutisch Instituut-(Riso)

Deventer, 7400 AC, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Twee Steden Ziekenhuis Vestiging Tilburg

Tilburg, 5042 AD, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Sophia Ziekehuis

Zwolle, 8000 GK, Netherlands

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (1)

• 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; 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. doi: 10.1016/j.ejca.2006.09.005. Epub 2006 Nov 3.

  PMID: 17084621 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Gemcitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Jose Belderbos, MD

  The Netherlands Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1999
• Primary Completion: March 1, 2003
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

DE (1); FR (1); GB (1); NL (12); BE (2)