Clinical trial NCT00039039: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival rate
Secondary outcomes:
measure: One-year survival rate and mean survival time
measure: Objective response rate and local control
measure: Tolerability
measure: Safety profile, in terms of acute and delayed toxicity
Other outcomes:
Locations:
city: Asti
country: Italy
facility: Ospedale Civile di Asti
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Carrara
country: Italy
facility: Civic Hospital of Carrara
city: Catanzaro
country: Italy
facility: Ospedale Regionale A. Pugliese
city: Cosenza
country: Italy
facility: Ospedale Mariano Santo
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri
city: Cuneo
country: Italy
facility: Ospedale Santa Croce
city: Genoa
country: Italy
facility: Ospedale Galliera Oncologia
city: Genoa
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Genoa
country: Italy
facility: Ospedale San Martino
city: Ivrea
country: Italy
facility: Ospedale Civile di Ivrea
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Lugo DI Romagna
country: Italy
facility: Ospedale Umberto I
city: Milan
country: Italy
facility: Istituto Policlinico San Donato
city: Milan
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Modena
country: Italy
facility: University of Modena Hospital and Reggio Emilia School of Medicine
city: Monza
country: Italy
facility: Nuovo Ospedale San Gerardo at University of Milano-Bicocca
city: Orbassano
country: Italy
facility: Azienda Ospedale S. Luigi at University of Torino
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Parma
country: Italy
facility: Azienda Ospedaliera Di Parma
city: Perugia
country: Italy
facility: Policlinico Monteluce
city: Pisa
country: Italy
facility: Ospedale Santa Chiara Pisa
city: Ravenna
country: Italy
facility: Ospedale Sta. Maria Delle Croci
city: Rome
country: Italy
facility: Ospedale Carlo Forlanini
city: Rome
country: Italy
facility: Ospedale S. Camillo-Forlanini
city: Rome
country: Italy
facility: Azienda Policlinico Umberto Primo
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri - Roma
city: Rome
country: Italy
facility: Istituto Regina Elena
city: San Giovanni - Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Turin
country: Italy
facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
city: Turin
country: Italy
facility: Ospedale Evangelico Valdese
city: Turin
country: Italy
facility: Ospedale Ostetrico Ginecologica Sant Anna
city: Udine
country: Italy
facility: Azienda Ospedaliera Santa Maria della Misericordia
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
Study officials:
affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Paolo Bruzzi, MD, MPH, PhD
role: STUDY_CHAIR
References: