Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00039039
- Lead Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel.
* Compare the 1-year survival rate and mean survival time in patients treated with these regimens.
* Compare the objective response rate and local control in patients treated with these regimens.
* Compare the tolerability of these regimens in these patients.
* Compare the safety profile and toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment.
* Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks.
* Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival rate
- Secondary Outcome Measures
Name Time Method One-year survival rate and mean survival time Objective response rate and local control Tolerability Safety profile, in terms of acute and delayed toxicity
Trial Locations
- Locations (37)
Ospedale Civile di Asti
🇮🇹Asti, Italy
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Civic Hospital of Carrara
🇮🇹Carrara, Italy
Ospedale Regionale A. Pugliese
🇮🇹Catanzaro, Italy
Ospedale Mariano Santo
🇮🇹Cosenza, Italy
Azienda Istituti Ospitalieri
🇮🇹Cremona, Italy
Ospedale Santa Croce
🇮🇹Cuneo, Italy
Ospedale Galliera Oncologia
🇮🇹Genoa, Italy
Scroll for more (27 remaining)Ospedale Civile di Asti🇮🇹Asti, Italy