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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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on June 6, 2002.   Last Updated on February 6, 2009   History of Changes
Sponsor: National Institute for Cancer Research, Italy
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039039
  Purpose

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: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Paclitaxel Carboplatin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One-year survival rate and mean survival time [ Designated as safety issue: No ]
  • Objective response rate and local control [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Safety profile, in terms of acute and delayed toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: February 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039039

Locations
Italy
Ospedale Civile di Asti
Asti, Italy, 14100
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Spedali Civili di Brescia
Brescia, Italy, 25133
Civic Hospital of Carrara
Carrara, Italy, I-54033
Ospedale Regionale A. Pugliese
Catanzaro, Italy, 88100
Ospedale Mariano Santo
Cosenza, Italy, 87100
Azienda Istituti Ospitalieri
Cremona, Italy, 26100
Ospedale Santa Croce
Cuneo, Italy, 12100
Ospedale San Martino
Genoa, Italy, 16132
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospedale Galliera Oncologia
Genoa, Italy, 16100
Ospedale Civile di Ivrea
Ivrea, Italy, 10015
Ospedale Santa Maria Goretti
Latina, Italy, 04100
Ospedale Umberto I
Lugo DI Romagna, Italy, 48022
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy, 20133
Istituto Policlinico San Donato
Milan, Italy, 20097
University of Modena Hospital and Reggio Emilia School of Medicine
Modena, Italy, 41100
Nuovo Ospedale San Gerardo at University of Milano-Bicocca
Monza, Italy, 20052
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
Policlinico Monteluce
Perugia, Italy, 06122
Ospedale Santa Chiara Pisa
Pisa, Italy, 56100
Ospedale Sta. Maria Delle Croci
Ravenna, Italy, 48100
Ospedale S. Camillo-Forlanini
Rome, Italy, 00152
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
Istituto Regina Elena
Rome, Italy, 00161
Ospedale Carlo Forlanini
Rome, Italy, 00149
Azienda Policlinico Umberto Primo
Rome, Italy, 00161
Ospedale Casa Sollievo della Sofferenza
San Giovanni - Rotondo, Italy, 71013
Azienda Ospedaliera S. Maria
Terni, Italy, 051100
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, Italy, 10123
Ospedale Ostetrico Ginecologica Sant Anna
Turin, Italy, 10125
Ospedale Evangelico Valdese
Turin, Italy, 10125
Azienda Ospedaliera Santa Maria della Misericordia
Udine, Italy, 33100
Ospedale San Bortolo
Vicenza, Italy, 36100
Sponsors and Collaborators
National Institute for Cancer Research, Italy
Investigators
Study Chair: Paolo Bruzzi, MD, MPH, PhD National Institute for Cancer Research, Italy
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00039039     History of Changes
Other Study ID Numbers: CDR0000068846, INRC-PITCAP, EU-20202, INRC-ITA, NCI-V01-1665
Study First Received: June 6, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Carboplatin
 Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012



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