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Lung CancerPhase 3NCT00077220

Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer

A Phase 3 study testing carboplatin, paclitaxel and adjuvant therapy in people with Lung Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 68 sites in France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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, such as paclitaxel and carboplatin, work in 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, paclitaxel and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
68 sitesFrance
Study dates
Jun 2002to 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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer
  • Stage II or III disease
  • Not amenable to surgery
  • Measurable or evaluable disease
  • No T4 apical localization
  • Lesions able to be covered in a 60 Gy minimum volume of radiation
  • No pleural effusion

PATIENT CHARACTERISTICS:

Age

  • 18 to 79

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)

Renal

  • Creatinine < 1.25 times ULN

Cardiovascular

  • No unstable heart disease

Pulmonary

  • No ventilation dysfunction that would preclude radiotherapy

Other

  • No weight loss of 15% or more within the past 2 months
  • No uncontrolled infection
  • No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 6 months since prior neoadjuvant chemotherapy
  • No prior adjuvant chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent clinical trial participation

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

France68 sites

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Institut Sainte Catherine

    Avignon, 84082

  • Hopital Duffaut

    Avignon, 84902

  • Centre Hospitalier Bayeux

    Bayeux, 14400

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • C.H.G. Beauvais

    Beauvais, 60021

  • Hopital Avicenne

    Bobigny, 93009

  • Clinique du Cedre

    Bois-Guillaume, 76230

  • Hopital Saint Andre

    Bordeaux, 33075

  • Clinique Tivoli

    Bordeaux, F-33000

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • Polyclinique Du Parc Centre Maurice Tubiana

    Caen, 14052

  • Hopital Louis Pasteur

    Chartres, 28018

  • Centre Hospitalier Chateaudun

    Châteaudun, 28200

  • Centre d'Oncologie et de Radiotherapie de Chaumont le Bois

    Chaumont, 52000

  • Centre Hospitalier Chaumont

    Chaumont, 52000

  • Hopital Louis Pasteur

    Comar, 68021

  • Clinique des Cedres

    Cornebarrieu, 31700

  • Centre d'Oncologie et de Radiotherapie du Parc

    Dijon, 21000

  • Hopital Jean Monnet

    Épinal, BP590

  • Centre Hospitalier D'Evreux

    Évreux, 27000

  • Clinique Pasteur

    Évreux, 27000

  • Clinique du Petit Colmouilins

    Harfleur, 76700

  • Centre Mallet - Proux

    Laval, 53000

  • C.H.G Laval

    Laval, 53024

  • Centre Guillaume Le Conquerant

    Le Havre, 76600

  • Centre Jean Bernard

    Le Mans, 72000

  • C. H. Du Mans

    Le Mans, 72037

  • Centre Hospitalier General

    Le Mans, 72037

  • Hopital Robert Boulin

    Libourne, 33500

  • Clinique de le Louviere

    Lille, F-59800

  • Clinique Chenieux

    Limoges, 87000

  • Centre Hospitalier Robert Bisson

    Lisieux, 14100

  • Medipole Gentilly Saint-Jacques

    Maxéville, 54320

  • Hopital Notre-Dame de Bon Secours

    Metz, 55038

  • Clinique du Pont de Chaume

    Montauban, 82017

  • C.H. Du Havre

    Montivilliers, F-76290

  • Polyclinique Saint - Roch

    Montpellier, 34000

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Clinique Clementville

    Montpellier

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Centre D'Oncologie De Gentilly

    Nancy, 54100

  • Clinique De Valdegour

    Nîmes, 30900

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Tenon

    Paris, 75970

  • C.H.G. De Pau

    Pau, 64000

  • Maison Medicale Marzet

    Pau, 64000

  • Clinique Saint - Pierre

    Perpignan

  • Clinique les Bleuets

    Reims, 51100

  • Groupe Medical St. Remy

    Reims, 51100

  • Polyclinique De Courlancy

    Reims, F-51100

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Frederic Joliot

    Rouen, 76000

  • Centre Hospitalier de Saint - Brieuc

    Saint-Brieuc, 22023

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Centre Hospitalier De Saint Dizier

    Saint-Dizier, 52100

  • Clinique Saint Vincent

    Saint-Grégoire, 35700

  • Clinique de l'Union

    Saint-Jean, 31240

  • Centre du Rouget

    Sarcelles, 95250

  • C. H. De Saumur

    Saumur, 49403

  • Clinique de l'Orangerie

    Strasbourg, 67010

  • Polyclinique de L'Ormeau

    Tarbes, 65000

  • Centre Hospitalier Regional Metz Thionville

    Thionville, 57126

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59300

  • Clinique Medico Chirurgicale Teissier Groupe

    Valenciennes

  • Centre Hospitalier De Vernon

    Vernon, 27200

Other trials in France

About this study

Official title: Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without adjuvant chemotherapy in treating unresectable stage II or stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying giving paclitaxel, carboplatin, and radiation therapy together with adjuvant paclitaxel and carboplatin to see how well it works compared to giving paclitaxel, carboplatin, and radiation therapy alone in treating patients with unresectable stage II or stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with or without adjuvant paclitaxel and carboplatin.

Secondary

  • Compare the objective response rate in patients treated with these regimens.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy regimen (conformational vs nonconformational).

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for up to 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 7-7.5 weeks. Three weeks after completion of chemoradiotherapy, patients with stable or responding disease are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo routine follow-up.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a maximum of 3 courses.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 390 patients will be accrued for this study within 3 years.

Conditions
Lung Cancer
Being tested
carboplatin, paclitaxel, adjuvant therapy, radiation therapy
Keywords
stage II 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. Progression-free survival

Secondary outcomes (3)

  1. Objective response rate

  2. Overall survival

  3. Toxicity

Timeline

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

  1. First posted11 Feb 2004 (estimated)
  2. Study startJun 2002

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077220
Sponsor's protocol ID
CDR0000350015
Other IDs
FRE-GERCOR-B00-1, EU-20330
Status last verified
May 2007
First submitted
10 Feb 2004
Last updated
9 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, paclitaxel and adjuvant therapy in people with Lung Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 68 sites in France.

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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in France. 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?

Progression-free survival. 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 NCT00077220.

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 9 Feb 2009.

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