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Lung CancerPhase 3NCT00003053

Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed

A Phase 3 study testing cisplatin, etoposide and adjuvant therapy in people with Lung Cancer, run by European Institute of Oncology at 86 sites in 3 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or… Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Lung Cancer
What is being tested?
cisplatin, etoposide and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
750 participants
Where
86 sitesin 3 countries
Study dates
Jan 1994to 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 Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven stage I, II, or IIIA non-small cell lung cancer after radical surgery
  • No evidence of lymphonodal enlargement during postsurgical chest CT scan

PATIENT CHARACTERISTICS:

Age:

  • 70 and under

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 1.5 times the upper limit of normal

Pulmonary:

  • FEV1 at least 1 liter

Other:

  • Less than 10% weight loss in the past 3 months
  • No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Radical surgery required

Trial locations and contacts

86 sites in 3 countries.

86 sites in 3 countries

Italy84 sites

  • Ospedale Bassini

    Balsamo Cinisello, 20092

  • Universita Degli Studi di Bari Policlinico

    Bari, 70124

  • Spedali Civili

    Brescia, 25124

  • Ospedale Oncologico A. Businco

    Cagliari, 09121

  • Cattedra di Oncologia Medica - Universita degli Studi di Cagliari

    Cagliari, 09124

  • Ospedale San Michele

    Cagliari, 09134

  • Ospedale Sant Anna

    Como, 22100

  • Ospedale Valduce

    Como, 22100

  • Ospedale Di Conselice

    Conselice, 48017

  • Ospedale Civile Cosenza

    Cosenza, 87100

  • Ospedale Maggiore Crema

    Crema, 26013

  • Ospedale Santa Croce

    Cuneo, 12100

  • Ospedale Civile Feltre

    Feltre, 32100

  • Universita di Ferrara

    Ferrara, 44100

  • Universita Degli Studi di Firenze - Policlin. di Careggi

    Firenze (Florence), 1 (50134)

  • Policlinico di Careggi

    Firenze (Florence), 50134

  • U.S.L. 10 Villa Ognissanti

    Florence, 50139

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa (Genova), 16132

  • Ospedale San Martino/Cliniche Universitarie Convenzionate

    Genoa (Genova), 16132

  • Ospedale Galliera Oncologia

    Genova (Genoa), 16128

  • Ospedale Di Gorgonzola

    Gorgonzola, 20064

  • Ospedale Alessandro Manzoni

    Lecco, 23900

  • Ospedale Legnago USSL 21

    Legnago, 37045

  • Ospedale Maggiore Lodi

    Lodi, I-20075

  • Ospedale Umberto I

    Lugo DI Romagna, 48022

  • U.S.S.L. 72 Magenta

    Magenta, 20013

  • Carlo Poma Hospital

    Mantua, 46100

  • Ospedale Di Predabissi Melegnano

    Melegnano, 20077

  • Azienda USSL NO 8

    Merate, 22055

  • Instituto Di Oncologia

    Messina, 98122

  • Ospedale Civile Umberto I

    Mestre, 30174

  • Ospedale San Giuseppe

    Milan, 20100

  • Consorzio Provinciale Antitubercolare

    Milan, 20124

  • Istituto Scientifico H.San Raffaele

    Milan, 20132

  • Istituto Di Science Biomediche San Paolo

    Milan, 20142

  • Casa Di Cura San Ambrogio

    Milan, 20149

  • Ospedale San Carlo Borromeo

    Milano (Milan), 20153

  • Ospedale Luigi Sacco

    Milano (Milan), 20157

  • Ospedale Maggiore Ca'Granda

    Milano (Milan), 20162

  • Ospedale Santa Croce

    Moncalieri, 10024

  • Nuovo Ospedale San Gerardo

    Monza, 20052

  • Ospedale Civile Asilo Vittoria

    Mortara, 27036

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

  • Ospedale Vincenzo Monaldi

    Naples, 80131

  • Ospedale C. Ascalesi

    Naples, 80139

  • Federico II University Medical School

    Naples (Napoli), 80131

  • Istituto Tumori/Fondazione Pascale

    Naples (Napoli), 80131

  • Ospedale Civile Negrar

    Negrar, 37024

  • Azienda Ospedaliera di Padova

    Padova (Padua), 35128

  • University of Padua

    Padua, 35128

  • Ospedale Civico E Benefratelli

    Palermo, 90127

  • Ospedale Maggiore Parma

    Parma, 43100

  • Ospedale Torrette University Ancona

    Parma, 43100

  • Ospedale Silvestrini

    Perugia, 06132

  • Ospedale Agnelli

    Pinerolo, 10064

  • Ospedale Sta. Maria Delle Croci

    Ravenna, 48100

  • Azienda Ospedaliera

    Reggio Emilia, 42100

  • Ospedale Civile Rho

    Rho, 20017

  • Istituti Fisioterapici Ospitalieri - Roma

    Rome, 00128

  • Ospedale San Filippo Neri

    Rome, 00135

  • Ospedale Carlo Forlanini

    Rome, 00149

  • Ospedale S. Camillo-Forlanini

    Rome, 00152

  • Azienda Policlinico Umberto Primo

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • Policlinico Militare Celio

    Rome, 00184

  • ASL NO. 1 Imperiese

    Sanremo, 18038

  • Consorzio Mario Negri Sud

    Santa Maria Imbaro, 66030

  • Azienda USSL No 4

    Saronno, 21047

  • Istituto Clinica Medica

    Sassari, 07100

  • Ospedale Sesto San Giovanni

    Sesto San Giovanni, 20099

  • Azienda Ospedaliera S. Maria

    Terni, 05100

  • Ospedale Generale Prov. Boldrini

    Thiene, 36016

  • Dispensario Igiene Sociale

    Toino, 10100

  • Clinica Universita

    Torino, 10126

  • Universita di Torino

    Torino, 10126

  • Ospedale S. Chiara

    Trento, 38100

  • Ospedale San Isidoro

    Trescore Balneario, 24069

  • Ospedale General Regional Ca Foncello

    Treviso, 31100

  • Ospedale Maggiore dell' Universita

    Trieste, 34100

  • Ospedale Cattinara

    Trieste

  • Cattedra di Immunologia Clinica

    Turin (TO), 10128

  • Universita Degli Studi di Udine

    Udine, 33100

  • Casa di Cura S. Maria

    Varese, 21100

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Greece1 site

  • George Papanicolaou General Hospital

    Thessaloniki, 57010

Other trials in Greece

South Korea1 site

  • Inha University Hospital

    Incheon

Other trials in South Korea

About this study

Official title: Adjuvant Treatment of 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed.

Read the detailed description

OBJECTIVES:

  • Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I, II, and IIIA non-small cell lung cancer.

OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA).

Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician.

PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.

Conditions
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA 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.

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 startJan 1994

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
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003053
Sponsor's protocol ID
CDR0000065700
Other IDs
CNR-NICO-01, EU-97010
Status last verified
Jan 2008
First submitted
1 Nov 1999
Last updated
20 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, etoposide and adjuvant therapy in people with Lung Cancer, run by European Institute of Oncology at 86 sites in 3 countries.

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 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Italy, Greece, South Korea. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003053.

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 20 Sep 2013.

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