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
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.
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
|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|
|Study Start Date:||February 1999|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
- 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.
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Hopital de Jolimont|
|Haine Saint Paul, Belgium, 7100|
|CHR de Grenoble - La Tronche|
|Grenoble, France, 38043|
|Mutterhaus der Borromaerinnen|
|Trier, Germany, D-54219|
|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|
|Breda, Netherlands, 4810 EV|
|Reinier de Graaf Group|
|Delft, Netherlands, NL 2600 GA|
|Deventer, Netherlands, 7400 AC|
|Eindhoven, Netherlands, 5602 ZA|
|Twee Steden Ziekenhuis Vestiging Tilburg|
|Tilburg, Netherlands, 5042 AD|
|Dr. Bernard Verbeeten Instituut|
|Tilburg, Netherlands, 5042 SB|
|Zwolle, Netherlands, 8000 GK|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Jose Belderbos, MD||The Netherlands Cancer Institute|