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Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer. Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer  Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Istituto Nazionale per la Ricerca sul Cancro ,
Synopsis: 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 unresectablestage III non-small cell lung cancer. PURPOSE: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) - Locoregionally advanced unresectable disease - Previously untreated - Measurable disease - No involvement of supraclavicular lymph nodes - No cytologically positive pleural or pericardial effusion - No invasion to the wall of the esophagus or the cardiac ventricle - No bone marrow involvement - No distant metastases PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - WHO 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - WBC greater than 4,000/mm^3 - Absolute neutrophil count greater than 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 10 g/dL Hepatic: - Bilirubin less than upper limit of normal (ULN) - AST and ALT less than 2.5 times ULN - Alkaline phosphatase less than 5 times ULN - No hepatic abnormalities Renal: - Creatinine less than ULN Cardiovascular: - No myocardial infarction within the past 6 months - No cardiac insufficiency - No uncontrolled arrhythmia Pulmonary: - FEV1 greater than 1 L - DLCO at least 30% predicted - No pneumonia - No other non-disease-related pulmonary complications Other: - No more than 10% of total weight loss over the past 6 months - No other disease that would preclude study - No peripheral neuropathy grade 3 or greater - No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No familial, geographic, or psychological condition that would preclude study - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy - No concurrent immunotherapy Chemotherapy: - No prior systemic chemotherapy Endocrine therapy: - No concurrent endocrine therapy Radiotherapy: - No prior radiotherapy for NSCLC Surgery: - See Disease Characteristics - No prior complete resection of tumor - Prior radical surgical resection allowed if local recurrence of disease - No concurrent major surgery Other: - No other concurrent anticancer therapy or investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaoloBruzzi, Study Chair, Istituto Nazionale per la Ricerca sul Cancro
Ospedale Carlo Forlanini *Recruiting*
Rome, , 00149
Italy
Recruiting Filippo Marinis 39-06-559-0731
Istituto Regina Elena *Recruiting*
Rome, , 00161
Italy
Recruiting Francesco Cognetti 39-06-4985-2201
Ospedale Umberto I *Recruiting*
Lugo DI Romagna, , 48022
Italy
Recruiting Giorgio Cruciani 39-0545-214-080
Ospedale Evangelico Valdese *Recruiting*
Torino, , 10125
Italy
Recruiting G. Fornari 39-011-654-0296
Ospedale Regionale A. Pugliese *Recruiting*
Catanzaro, , 88100
Italy
Recruiting Domenico Pingitore 39-0961-8837-4618
Ospedale Santa Croce *Recruiting*
Cuneo, , 12100
Italy
Recruiting Giuseppe Marchetti 39-0171-641-226
Nuovo Ospedale San Gerardo *Recruiting*
Monza, , 20052
Italy
Recruiting Antonio Ardizzoia 39-039-233-3681 (2333679)
Azienda Ospedaliera Santa Maria della Misericordia *Recruiting*
Udine, , 33100
Italy
Recruiting Tino Ceschia 39-0432-552-900
Ospedale Mariano Santo *Recruiting*
Cosenza, , 87100
Italy
Recruiting Paolo Montemaggi 39-0984-681-729
Ospedale Sta. Maria Delle Croci *Recruiting*
Ravenna, , 48100
Italy
Recruiting Ermanno Emiliani 39-0544-285-244
Azienda Policlinico Umberto Primo *Recruiting*
Rome, , 00161
Italy
Recruiting Enrico Cortesi 39-06-494-1035
Azienda Ospedaliera S. Maria *Recruiting*
Terni, , 05100
Italy
Recruiting Francesco Costanzo 39-0744-205-225 Ext. 202574 or
Ospedale Casa Sollievo della Sofferenza *Recruiting*
San Giovanni Rotondo, , 71013
Italy
Recruiting Giorgio Lelli 39-0882-612-792
Policlinico Monteluce *Recruiting*
Perugia, , 06122
Italy
Recruiting Maurizio Tonato 39-075-578-3456
Ospedale S. Camillo-Forlanini *Recruiting*
Rome, , 00152
Italy
Recruiting Maria Ammaturo 39-06-5870-959
Ospedale Galliera Oncologia *Recruiting*
Genova, , 16100
Italy
Recruiting Angelo Siragusa 39-010-563-4830
Ospedale Gen. Provinciale Santa Maria Goretti *Recruiting*
Latina, , 04100
Italy
Recruiting Giancarlo Arcangeli 39-0773-655-651
Ospedali Riuniti di Bergamo *Recruiting*
Bergamo, , 24100
Italy
Recruiting Alberto Personeni 39-035-269-519
Azienda Istituti Ospitalieri *Recruiting*
Cremona, , 26100
Italy
Recruiting Alberto Bonetta 39-0372-405-567
Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Torino *Recruiting*
Turin (Torino), , 10123
Italy
Recruiting Alessandro Trotti 39-011-566-4070
Ospedale S. Giovanni Battista *Recruiting*
Torino, , 10126
Italy
Recruiting Maria Tessa 39-011-633-6613
Istituto Nazionale per la Ricerca sul Cancro *Recruiting*
Genoa (Genova), , 16132
Italy
Recruiting Andrea Ardizzoni 39-010-560-0668
Azienda Ospedale S. Luigi - Universita Di Torino *Recruiting*
Orbassano, (Torino), , 10043
Italy
Recruiting Giorgio Scagliotti 39-11-902-6414
Ospedale San Bortolo *Recruiting*
Vicenza, , 36100
Italy
Recruiting Gianpaolo Bolzicco 39-0444-993-695
Civic Hospital of Carrara *Recruiting*
Carrara, , I-54033
Italy
Recruiting Angiolo Tagliagambe 39-0585-7671
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milano (Milan), , 20133
Italy
Recruiting Emilio Bajetta 39-02-2390-500
Azienda Ospedaliera Di Parma *Recruiting*
Parma, , 43100
Italy
Recruiting Angelo Cuomo 39-0521-991-441
Istituti Fisioterapici Ospitalieri - Roma *Recruiting*
Rome, , 00161
Italy
Recruiting Massimo Lopez 39-06-4985-2295
Ospedale Civile di Ivrea *Recruiting*
Ivrea (TO), , 10015
Italy
Recruiting Franca Ozzello 39-0125-414-239
Ospedale Civile di Asti *Recruiting*
Asti, , 14100
Italy
Recruiting Franco Testore 39-0141-392-323
Centro di Riferimento Oncologico - Aviano *Recruiting*
Aviano, , 33081
Italy
Recruiting Emilio Minatel 39-0434-659-525
Universita di Modena *Recruiting*
Modena, , 41100
Italy
Recruiting Mario Balli 39-059-422-2301
Ospedale Santa Chiara *Recruiting*
Pisa, , 56100
Italy
Recruiting Luca Cionini 39-050-992-540
Azienda Ospedaliera di Padova *Recruiting*
Padova (Padua), , 35128
Italy
Recruiting Guido Sotti 39-049-821-2105
OIRM - Sant Anna *Recruiting*
Torino, , 10125
Italy
Recruiting Alessandro Urgesi 39-011-313-4563
Ospedale San Martino/Cliniche Universitarie Convenzionate *Recruiting*
Genoa, , 16132
Italy
Recruiting Alberto Sobrero 39-010-555-3977
Spedali Civili di Brescia *Recruiting*
Brescia, , 25133
Italy
Recruiting A. Caprioli 39-030-399-5595
Istituto Policlinico San Donato *Recruiting*
Milan, , 20097
Italy
Recruiting Fabrizio Lombardi 39-02-5277-4419
Additional Information:
Study ID Numbers: CDR0000068846; INRC-ITA,NCI-V01-1665,EU-20202,INRC-PITCAP
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039039
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
2. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
3. Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
4. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
5. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Genoa Clinical Trials
Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
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