Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: carboplatin; Radiation: radiation therapy; Drug: chemotherapy; Drug: cisplatin; Drug: paclitaxel

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Asti, Italy, 14100
    • Ospedale Civile di Asti
  • Aviano, Italy, 33081
    • Centro di Riferimento Oncologico - Aviano
  • Bergamo, Italy, 24100
    • Ospedali Riuniti di Bergamo
  • Brescia, Italy, 25133
    • Spedali Civili di Brescia
  • Carrara, Italy, I-54033
    • Civic Hospital of Carrara
  • Catanzaro, Italy, 88100
    • Ospedale Regionale A. Pugliese
  • Cosenza, Italy, 87100
    • Ospedale Mariano Santo
  • Cremona, Italy, 26100
    • Azienda Istituti Ospitalieri
  • Cuneo, Italy, 12100
    • Ospedale Santa Croce
  • Genoa, Italy, 16100
    • Ospedale Galliera Oncologia
  • Genoa, Italy, 16132
    • Istituto nazionale Per la Ricerca sul Cancro
  • Genoa, Italy, 16132
    • Ospedale San Martino
  • Ivrea, Italy, 10015
    • Ospedale Civile di Ivrea
  • Latina, Italy, 04100
    • Ospedale Santa Maria Goretti
  • Lugo DI Romagna, Italy, 48022
    • Ospedale Umberto I
  • Milan, Italy, 20097
    • Istituto Policlinico San Donato
  • Milan, Italy, 20133
    • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
  • Modena, Italy, 41100
    • University of Modena Hospital and Reggio Emilia School of Medicine
  • Monza, Italy, 20052
    • Nuovo Ospedale San Gerardo at University of Milano-Bicocca
  • Orbassano, Italy, 10043
    • Azienda Ospedale S. Luigi at University of Torino
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Parma, Italy, 43100
    • Azienda Ospedaliera Di Parma
  • Perugia, Italy, 06122
    • Policlinico Monteluce
  • Pisa, Italy, 56100
    • Ospedale Santa Chiara Pisa
  • Ravenna, Italy, 48100
    • Ospedale Sta. Maria Delle Croci
  • Rome, Italy, 00149
    • Ospedale Carlo Forlanini
  • Rome, Italy, 00152
    • Ospedale S. Camillo-Forlanini
  • Rome, Italy, 00161
    • Azienda Policlinico Umberto Primo
  • Rome, Italy, 00161
    • Istituti Fisioterapici Ospitalieri - Roma
  • Rome, Italy, 00161
    • Istituto Regina Elena
  • San Giovanni - Rotondo, Italy, 71013
    • Ospedale Casa Sollievo della Sofferenza
  • Terni, Italy, 051100
    • Azienda Ospedaliera S. Maria
  • Turin, Italy, 10123
    • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Turin, Italy, 10125
    • Ospedale Evangelico Valdese
  • Turin, Italy, 10125
    • Ospedale Ostetrico Ginecologica Sant Anna
  • Udine, Italy, 33100
    • Azienda Ospedaliera Santa Maria Della Misericordia
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival rate

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Investigators: Study Chair: Paolo Bruzzi, MD, MPH, PhD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 6, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Cisplatin
• Other Study ID Numbers: CDR0000068846; INRC-PITCAP; EU-20202; INRC-ITA; NCI-V01-1665

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No