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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003803
• Other study ID #: EORTC-08972-22973
• Secondary ID: EORTC-08972
• Status: Terminated
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 17, 2012
• Start date: February 1999

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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerp
Belgium	Hopital de Jolimont	Haine Saint Paul
France	CHR de Grenoble - La Tronche	Grenoble
Germany	Mutterhaus der Borromaerinnen	Trier
Netherlands	Medisch Centrum Haaglanden	's-Gravenhage (Den Haag, The Hague)
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Gelre Ziekenhuizen - Lokatie Lukas	Apeldoorn
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Amphia Ziekenhuis - locatie Molengracht	Breda
Netherlands	Reinier de Graaf Group	Delft
Netherlands	Radiotherapeutisch Instituut-(Riso)	Deventer
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Netherlands	Twee Steden Ziekenhuis Vestiging Tilburg	Tilburg
Netherlands	Sophia Ziekehuis	Zwolle
United Kingdom	Western General Hospital	Edinburgh	Scotland

Sponsors (1)

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

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  United Kingdom, 

References & 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-radiothera — View Citation