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Sponsored by: |
National Institute for Cancer Research, Italy |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039039 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: chemotherapy Drug: cisplatin Drug: paclitaxel Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer |
Estimated Enrollment: | 300 |
Study Start Date: | February 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Italy | |
Azienda Istituti Ospitalieri | |
Cremona, Italy, 26100 | |
Azienda Ospedale S. Luigi at University of Torino | |
Orbassano, Italy, 10043 | |
Azienda Ospedaliera di Padova | |
Padova, Italy, 35128 | |
Azienda Ospedaliera Di Parma | |
Parma, Italy, 43100 | |
Azienda Ospedaliera S. Maria | |
Terni, Italy, 051100 | |
Azienda Ospedaliera Santa Maria della Misericordia | |
Udine, Italy, 33100 | |
Azienda Policlinico Umberto Primo | |
Rome, Italy, 00161 | |
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | |
Turin, Italy, 10123 | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 | |
Civic Hospital of Carrara | |
Carrara, Italy, I-54033 | |
Istituti Fisioterapici Ospitalieri - Roma | |
Rome, Italy, 00161 | |
Istituto Nazionale per la Ricerca sul Cancro | |
Genoa, Italy, 16132 | |
Istituto Nazionale per lo Studio e la Cura dei Tumori | |
Milan, Italy, 20133 | |
Istituto Policlinico San Donato | |
Milan, Italy, 20097 | |
Istituto Regina Elena | |
Rome, Italy, 00161 | |
Nuovo Ospedale San Gerardo at University of Milano-Bicocca | |
Monza, Italy, 20052 | |
Ospedale Carlo Forlanini | |
Rome, Italy, 00149 | |
Ospedale Casa Sollievo della Sofferenza | |
San Giovanni - Rotondo, Italy, 71013 | |
University of Modena Hospital and Reggio Emilia School of Medicine | |
Modena, Italy, 41100 | |
Ospedale Civile di Ivrea | |
Ivrea, Italy, 10015 | |
Ospedale Evangelico Valdese | |
Turin, Italy, 10125 | |
Ospedale Galliera Oncologia | |
Genoa, Italy, 16100 | |
Ospedale Mariano Santo | |
Cosenza, Italy, 87100 | |
Ospedale Ostetrico Ginecologica Sant Anna | |
Turin, Italy, 10125 | |
Ospedale Regionale A. Pugliese | |
Catanzaro, Italy, 88100 | |
Ospedale S. Camillo-Forlanini | |
Rome, Italy, 00152 | |
Ospedale San Bortolo | |
Vicenza, Italy, 36100 | |
Ospedale San Martino | |
Genoa, Italy, 16132 | |
Ospedale Santa Chiara Pisa | |
Pisa, Italy, 56100 | |
Ospedale Santa Croce | |
Cuneo, Italy, 12100 | |
Ospedale Santa Maria Goretti | |
Latina, Italy, 04100 | |
Ospedale Sta. Maria Delle Croci | |
Ravenna, Italy, 48100 | |
Ospedale Umberto I | |
Lugo DI Romagna, Italy, 48022 | |
Ospedali Riuniti di Bergamo | |
Bergamo, Italy, 24100 | |
Policlinico Monteluce | |
Perugia, Italy, 06122 | |
Spedali Civili di Brescia | |
Brescia, Italy, 25133 | |
Ospedale Civile di Asti | |
Asti, Italy, 14100 |
Study Chair: | Paolo Bruzzi, MD, MPH, PhD | National Institute for Cancer Research, Italy |
Study ID Numbers: | CDR0000068846, INRC-PITCAP, EU-20202, INRC-ITA, NCI-V01-1665 |
Study First Received: | June 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00039039 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Antimitotic Agents Carboplatin Recurrence Carcinoma Respiratory Tract Diseases Cisplatin Radiation-Sensitizing Agents |
Lung Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Paclitaxel Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |