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AzTrials

Lung CancerPhase 3NCT00039039

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

A Phase 3 study testing carboplatin, chemotherapy and cisplatin in people with Lung Cancer, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 37 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, chemotherapy and cisplatin
Type of treatment
Surgery or procedure
How many people
300 participants
Where
37 sitesItaly
Study dates
Feb 2000to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Italy37 sites

  • Ospedale Civile di Asti

    Asti, 14100

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

  • Spedali Civili di Brescia

    Brescia, 25133

  • Civic Hospital of Carrara

    Carrara, I-54033

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

  • Ospedale Mariano Santo

    Cosenza, 87100

  • Azienda Istituti Ospitalieri

    Cremona, 26100

  • Ospedale Santa Croce

    Cuneo, 12100

  • Ospedale Galliera Oncologia

    Genoa, 16100

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa, 16132

  • Ospedale San Martino

    Genoa, 16132

  • Ospedale Civile di Ivrea

    Ivrea, 10015

  • Ospedale Santa Maria Goretti

    Latina, 04100

  • Ospedale Umberto I

    Lugo DI Romagna, 48022

  • Istituto Policlinico San Donato

    Milan, 20097

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milan, 20133

  • University of Modena Hospital and Reggio Emilia School of Medicine

    Modena, 41100

  • Nuovo Ospedale San Gerardo at University of Milano-Bicocca

    Monza, 20052

  • Azienda Ospedale S. Luigi at University of Torino

    Orbassano, 10043

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliera Di Parma

    Parma, 43100

  • Policlinico Monteluce

    Perugia, 06122

  • Ospedale Santa Chiara Pisa

    Pisa, 56100

  • Ospedale Sta. Maria Delle Croci

    Ravenna, 48100

  • Ospedale Carlo Forlanini

    Rome, 00149

  • Ospedale S. Camillo-Forlanini

    Rome, 00152

  • Azienda Policlinico Umberto Primo

    Rome, 00161

  • Istituti Fisioterapici Ospitalieri - Roma

    Rome, 00161

  • Istituto Regina Elena

    Rome, 00161

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera S. Maria

    Terni, 051100

  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

    Turin, 10123

  • Ospedale Evangelico Valdese

    Turin, 10125

  • Ospedale Ostetrico Ginecologica Sant Anna

    Turin, 10125

  • Azienda Ospedaliera Santa Maria della Misericordia

    Udine, 33100

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
carboplatin, chemotherapy, cisplatin, paclitaxel, radiation therapy
Keywords
recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival rate

Secondary outcomes (4)

  1. One-year survival rate and mean survival time

  2. Objective response rate and local control

  3. Tolerability

  4. Safety profile, in terms of acute and delayed toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039039
Sponsor's protocol ID
CDR0000068846
Other IDs
INRC-PITCAP, EU-20202, INRC-ITA, NCI-V01-1665
Status last verified
Aug 2006
First submitted
6 Jun 2002
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, chemotherapy and cisplatin in people with Lung Cancer, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 37 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00039039.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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