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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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
carboplatin
chemotherapy
cisplatin
paclitaxel
radiation therapy
Sponsored by
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile di Asti
  • Centro di Riferimento Oncologico - Aviano
  • Ospedali Riuniti di Bergamo
  • Spedali Civili di Brescia
  • Civic Hospital of Carrara
  • Ospedale Regionale A. Pugliese
  • Ospedale Mariano Santo
  • Azienda Istituti Ospitalieri
  • Ospedale Santa Croce
  • Ospedale Galliera Oncologia
  • Istituto Nazionale per la Ricerca sul Cancro
  • Ospedale San Martino
  • Ospedale Civile di Ivrea
  • Ospedale Santa Maria Goretti
  • Ospedale Umberto I
  • Istituto Policlinico San Donato
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • University of Modena Hospital and Reggio Emilia School of Medicine
  • Nuovo Ospedale San Gerardo at University of Milano-Bicocca
  • Azienda Ospedale S. Luigi at University of Torino
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera Di Parma
  • Policlinico Monteluce
  • Ospedale Santa Chiara Pisa
  • Ospedale Sta. Maria Delle Croci
  • Ospedale Carlo Forlanini
  • Ospedale S. Camillo-Forlanini
  • Azienda Policlinico Umberto Primo
  • Istituti Fisioterapici Ospitalieri - Roma
  • Istituto Regina Elena
  • Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliera S. Maria
  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Ospedale Evangelico Valdese
  • Ospedale Ostetrico Ginecologica Sant Anna
  • Azienda Ospedaliera Santa Maria della Misericordia
  • Ospedale San Bortolo

Outcomes

Primary Outcome Measures

Overall survival rate

Secondary Outcome Measures

One-year survival rate and mean survival time
Objective response rate and local control
Tolerability
Safety profile, in terms of acute and delayed toxicity

Full Information

First Posted
June 6, 2002
Last Updated
December 17, 2013
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00039039
Brief Title
Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Overall survival rate
Secondary Outcome Measure Information:
Title
One-year survival rate and mean survival time
Title
Objective response rate and local control
Title
Tolerability
Title
Safety profile, in terms of acute and delayed toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bruzzi, MD, MPH, PhD
Organizational Affiliation
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Civile di Asti
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25133
Country
Italy
Facility Name
Civic Hospital of Carrara
City
Carrara
ZIP/Postal Code
I-54033
Country
Italy
Facility Name
Ospedale Regionale A. Pugliese
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale Mariano Santo
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Facility Name
Azienda Istituti Ospitalieri
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ospedale Galliera Oncologia
City
Genoa
ZIP/Postal Code
16100
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Martino
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Civile di Ivrea
City
Ivrea
ZIP/Postal Code
10015
Country
Italy
Facility Name
Ospedale Santa Maria Goretti
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Ospedale Umberto I
City
Lugo DI Romagna
ZIP/Postal Code
48022
Country
Italy
Facility Name
Istituto Policlinico San Donato
City
Milan
ZIP/Postal Code
20097
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
University of Modena Hospital and Reggio Emilia School of Medicine
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Nuovo Ospedale San Gerardo at University of Milano-Bicocca
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedale S. Luigi at University of Torino
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Policlinico Monteluce
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Ospedale Santa Chiara Pisa
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Ospedale Sta. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Ospedale Carlo Forlanini
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Ospedale S. Camillo-Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Policlinico Umberto Primo
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituti Fisioterapici Ospitalieri - Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Regina Elena
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni - Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
ZIP/Postal Code
051100
Country
Italy
Facility Name
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
City
Turin
ZIP/Postal Code
10123
Country
Italy
Facility Name
Ospedale Evangelico Valdese
City
Turin
ZIP/Postal Code
10125
Country
Italy
Facility Name
Ospedale Ostetrico Ginecologica Sant Anna
City
Turin
ZIP/Postal Code
10125
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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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