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Carcinoma, Non-Small-Cell LungPhase 3NCT00535275

NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy

A Phase 3 study testing Chemotherapy with platine and Chemotherapy without Cisplatine in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 78 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Relapses after perioperative chemotherapy and surgery Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Chemotherapy with platine and Chemotherapy without Cisplatine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
78 sitesFrance
Study dates
Sep 2007to Nov 2014
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radio-therapy (local or metastatic relapse).
  • Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a platinum containing regimen)
  • Initial stage pT1N0 to pT3N2 (TNM classification 1999), complete resection. T4 tumours (several nodules in the same lobe) and M1 tumours (several nodules in the same lung) N0-2 completely resected are allowed to inclusion. Histological complete response tumours (pT0N0) after neoadjuvant chemotherapy are allowed to inclusion.
  • At least one unidimensionally measurable disease (RECIST criteria) (lesions must have clearly defined margins on X-ray, CT-scan, MRI or ultra-sound (US) examination and should measure at least 1 cm if assessed by CT, MRI or US and at least 2 cm if assessed by X-ray, target lesions should be selected outside a previously irradiated field ). PET scans and ultra sonography are not allowed
  • ECOG Performance status 0 to 1).
  • Patients with adequate biological functions:
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  • Written informed consent from patient.
  • The effects of docetaxel, cisplatin and carboplatin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because docetaxel, cisplatin and carboplatin as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Life expectancy > 12 weeks
  • Patient compliance and geographic proximity that allow adequate follow-up.
  • Patient affiliated to a social insurance program

Who cannot join

  • Previous treatment with docetaxel.
  • Hypersensitivity to docetaxel, cisplatin, carboplatin or polysorbate 80 (excipient).
  • Previous history of cancer other than Non small cell lung cancer, in situ carcinoma of the uterine cervix and basal cell carcinoma of the skin.
  • Patients previously treated by an investigational agent in the last 30 days.
  • Patient treated with preoperative platin based chemotherapy, achieving a progression of disease after treatment evaluation.
  • Patients non responders to preoperative chemotherapy and whose tumor specimen did not disclose any necrosis nor tumoral modification thus confirming the lack of chemosensitivity to platin based chemotherapy
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  • Patient treated with platin based adjuvant chemotherapy, relapsing within the first 6 months after surgery.
  • Patients with a peripheral neuropathy grade CTC >= 2
  • Patients unable to fulfill protocol requirements
  • Serious concomitant morbidity incompatible with the study (at the discretion of the investigator).
  • Relapse within the month following lung cancer resection or adjuvant chemotherapy
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Significant loss of weight (> 10 %) in the 6 weeks preceding patient selection.
  • Concomitant administration of another anti cancer treatment
  • Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
  • Patient under legal protection.

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

France78 sites

  • Centre Hospitalier

    Aix-en-Provence

  • Annemasse - CH

    Ambilly, 74100

  • Annecy - CH

    Annecy, 74374

  • Auxerre - Polyclinique

    Auxerre, 89000

  • Auxerre - CH

    Auxerre, 89011

  • CH de la Côte Basque

    Bayonne

  • Beauvais - CH

    Beauvais, 60021

  • CHU Besancon - Pneumologie

    Besançon, 25000

  • Blois - CH

    Blois, 41016

  • APHP - CHU Avicenne - Oncologie Medicale

    Bobigny, 93000

  • Boulogne - Ambroise Paré

    Boulogne

  • Caen - Centre François Baclesse

    Caen, 14000

  • CHU - Pneumologie

    Caen, 14000

  • Calais - CH

    Calais, 62017

  • CH de Cannes

    Cannes

  • Chambray Les Tours - Clinique Léonard de Vinci

    Chambray-lès-Tours, 37170

  • Chauny - CH

    Chauny

  • Chevilly-Larue - CH

    Chevilly-Larue, 94669

  • Hôpital de Cholet - Pneumologie

    Cholet

  • Hôpital Percy-Armées - Pneumologie

    Clamart, 92140

  • Hôpitral Gabriel Montpied - Pneumologie

    Clermont-Ferrand

  • CH

    Colmar

  • CHI Créteil

    Créteil

  • Dax - CH

    Dax, 40107

  • Dijon - CHU

    Dijon, 21079

  • Epinal - CH

    Épinal, 88021

  • CHU

    Grenoble

  • Saint Omer - CHI

    Helfaut, 62570

  • La Roche Sur Yon - CH

    La Roche-sur-Yon, 85925

  • Chartres - CH

    Le Coudray, 28630

  • Le Mans - Centre Hospitalier

    Le Mans, 72000

  • Limoges - Hôpital du Cluzeau

    Limoges, 87042

  • CH de Longjumeau

    Longjumeau

  • HCL - Croix-Rousse

    Lyon, 69000

  • Lyon - Clinique Mutualiste

    Lyon, 69003

  • Hôpital Louis Pradel

    Lyon

  • CH de Macon

    Mâcon

  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

    Marseille

  • Maubeuge - Polyclinique du Parc

    Maubeuge, 59600

  • Meaux - CH

    Meaux, 77100

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Centre Hospitalier

    Montélimar

  • Moulins - CH

    Moulins, 03000

  • Mulhouse - CH

    Mulhouse, 68000

  • CHU

    Nancy

  • Nanterre - CH

    Nanterre, 92014

  • Nantes - Centre René Gauducheau

    Nantes, 44805

  • CH Nevers

    Nevers

  • Nîmes - Clinique Valdegour

    Nîmes, 30900

  • Orléans - CH

    Orléans, 45000

  • APHP - Hopital Tenon - Pneumologie

    Paris, 75020

  • GH Paris Saint-Joseph

    Paris

  • Hôpital Saint Antoine

    Paris

  • Centre Catalan d'Onologie

    Perpignan, 66000

  • Perpignan - Ch

    Perpignan, 66046

  • HCL - Lyon Sud (Pneumologie)

    Pierre-Bénite, 69495

  • Centre Hospitalier

    Rambouillet

  • Reims - CHU

    Reims, 51092

  • Institut Jean Godinot

    Reims

  • Rodez - CH

    Rodez, 12021

  • Roncq - Clinique Saint-Roch

    Roncq, 59223

  • Roubaix - CH

    Roubaix, 59100

  • CH de Saint-Brieuc

    Saint-Brieuc

  • Saint Nazaire - Centre Etienne Dolet

    Saint-Nazaire, 44600

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • Saint Quentin - CH

    Saint-Quentin, 02100

  • Saint-Malo - CH

    St-Malo, 35403

  • CHU Lyautey - Pneumologie

    Strasbourg, 63000

  • Hôpital Foch

    Suresnes

  • Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses

    Thonon-les-Bains

  • Toulon - CHI

    Toulon, 83000

  • Toulouse - CHU Larrey

    Toulouse

  • Tours - CHU

    Tours, 37000

  • Troyes - CH

    Troyes, 10000

  • Valenciennes - Clinique

    Valenciennes, 59304

  • CHI de la Haute-Saône - Pneumologie

    Vesoul

  • Vienne - CH

    Vienne, 38200

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

Relapses after perioperative chemotherapy and surgery

Read the detailed description

As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel).

Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases.

Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV.

  • Patients are most often in a good condition (performance status 0-1).
  • Progression is often asymptomatic and diagnosed in the post surgical follow up.
  • The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV.
  • The time between the first line of treatment and the treatment of the relapse is longer.

These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet instead of the classical mono chemotherapy docetaxel or pemetrexed.

Thus, the current study has been designed to answer these questions.

Being tested
Chemotherapy with platine, Chemotherapy without Cisplatine
Keywords
NSCLC relapse after adjuvant chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Chemotherapy with platineDrug

    Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

  • Chemotherapy without CisplatineDrug

    Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)

Study groups in NCT00535275
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Chemotherapy with platine
BActive comparatorDocetaxel monotherapy
Receives: Drug: Chemotherapy without Cisplatine

What is being measured

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

  1. progression-free survival (PFS)

    Measured: one year

Timeline

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

  1. First posted26 Sep 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Final analysis done, follow-up of patients no more necessary

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
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00535275
Sponsor's protocol ID
IFCT-0702
Status last verified
Feb 2015
First submitted
25 Sep 2007
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy with platine and Chemotherapy without Cisplatine in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 78 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?

The sponsor lists 11 inclusion and 16 exclusion criteria. 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: stopped early, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 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?

The study was stopped early (reason given: Final analysis done, follow-up of patients no more necessary). 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 (PFS) (time frame: one year). 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 NCT00535275.

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 16 Feb 2015.

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