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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00039039
• Other study ID #: CDR0000068846
• Secondary ID: INRC-PITCAPEU-20
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 6, 2002
• Last updated: December 17, 2013
• Start date: February 2000

Study information

• Verified date: August 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• chemotherapy

• cisplatin

• paclitaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Italy	Ospedale Civile di Asti	Asti
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Spedali Civili di Brescia	Brescia
Italy	Civic Hospital of Carrara	Carrara
Italy	Ospedale Regionale A. Pugliese	Catanzaro
Italy	Ospedale Mariano Santo	Cosenza
Italy	Azienda Istituti Ospitalieri	Cremona
Italy	Ospedale Santa Croce	Cuneo
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa
Italy	Ospedale Galliera Oncologia	Genoa
Italy	Ospedale San Martino	Genoa
Italy	Ospedale Civile di Ivrea	Ivrea
Italy	Ospedale Santa Maria Goretti	Latina
Italy	Ospedale Umberto I	Lugo DI Romagna
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milan
Italy	Istituto Policlinico San Donato	Milan
Italy	University of Modena Hospital and Reggio Emilia School of Medicine	Modena
Italy	Nuovo Ospedale San Gerardo at University of Milano-Bicocca	Monza
Italy	Azienda Ospedale S. Luigi at University of Torino	Orbassano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera Di Parma	Parma
Italy	Policlinico Monteluce	Perugia
Italy	Ospedale Santa Chiara Pisa	Pisa
Italy	Ospedale Sta. Maria Delle Croci	Ravenna
Italy	Azienda Policlinico Umberto Primo	Rome
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Italy	Istituto Regina Elena	Rome
Italy	Ospedale Carlo Forlanini	Rome
Italy	Ospedale S. Camillo-Forlanini	Rome
Italy	Ospedale Casa Sollievo della Sofferenza	San Giovanni - Rotondo
Italy	Azienda Ospedaliera S. Maria	Terni
Italy	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino	Turin
Italy	Ospedale Evangelico Valdese	Turin
Italy	Ospedale Ostetrico Ginecologica Sant Anna	Turin
Italy	Azienda Ospedaliera Santa Maria della Misericordia	Udine
Italy	Ospedale San Bortolo	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Cancer Research, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate			No
Secondary	One-year survival rate and mean survival time			No
Secondary	Objective response rate and local control			No
Secondary	Tolerability			Yes
Secondary	Safety profile, in terms of acute and delayed toxicity			Yes