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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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
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 I non-small cell lung cancer, stage II non-small cell lung cancer, stage III non-small cell lung cancer

Eligibility Criteria

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

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

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • Hopital de Jolimont
  • CHR de Grenoble - La Tronche
  • Mutterhaus der Borromaerinnen
  • Medisch Centrum Haaglanden
  • Antoni van Leeuwenhoekhuis
  • Academisch Medisch Centrum
  • Gelre Ziekenhuizen - Lokatie Lukas
  • Amphia Ziekenhuis
  • Amphia Ziekenhuis - locatie Molengracht
  • Reinier de Graaf Group
  • Radiotherapeutisch Instituut-(Riso)
  • Catharina Ziekenhuis
  • Twee Steden Ziekenhuis Vestiging Tilburg
  • Dr. Bernard Verbeeten Instituut
  • Sophia Ziekehuis
  • Western General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
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
NCT00003803
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
February 1999 (undefined)
Primary Completion Date
March 2003 (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 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Belderbos, MD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Mutterhaus der Borromaerinnen
City
Trier
ZIP/Postal Code
D-54219
Country
Germany
Facility Name
Medisch Centrum Haaglanden
City
's-Gravenhage (Den Haag, The Hague)
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Gelre Ziekenhuizen - Lokatie Lukas
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4810 EV
Country
Netherlands
Facility Name
Amphia Ziekenhuis - locatie Molengracht
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Reinier de Graaf Group
City
Delft
ZIP/Postal Code
NL 2600 GA
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut-(Riso)
City
Deventer
ZIP/Postal Code
7400 AC
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5602 ZA
Country
Netherlands
Facility Name
Twee Steden Ziekenhuis Vestiging Tilburg
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Sophia Ziekehuis
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17084621
Citation
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.
Results Reference
result

Learn more about this trial

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

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