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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-004840-30
    Sponsor's Protocol Code Number:TREAT
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-004840-30
    A.3Full title of the trial
    ADJUVANT CHEMOTHERAPY WITH PEMETREXED AND CISPLATIN vs. VINORELBINE AND CISPLATIN IN NSCLC IB, IIA, IIB, T3N1: A RANDOMIZED PHASE II STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the improvement of chemotherapy in early detected
    lung cancer after surgery
    A.3.2Name or abbreviated title of the trial where available
    TREAT
    A.4.1Sponsor's protocol code numberTREAT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThoraxklinik Heidelberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly Benelux
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThoraxklinik Heidelberg
    B.5.2Functional name of contact pointProf. Dr. Michael Thomas
    B.5.3 Address:
    B.5.3.1Street AddressAmalienstr. 5
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69126
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962213961301
    B.5.5Fax number+4962213961302
    B.5.6E-mailmichael.thomas@thoraxklinik-heidelberg.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Alimta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePemetrexed
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPemetrexed
    D.3.9.1CAS number 137281233
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with pathologically confirmed, R0 resected non-small cell lung cancer (NSCLC), pathologic stage IB, IIA, IIB, T3N1 (without need for further radiotherapy); systematic lymph node dissection is required with resection.
    E.1.1.1Medical condition in easily understood language
    Patients with confirmed and surgically removed lung cancer including
    removal of lymph nodes which not require irradiation
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025044
    E.1.2Term Lung cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Cisplatin vs. Vinorelbine and Cisplatin in patients with NSCLC stage IB, IIA, IIB and T3N1 (without need for further radiotherapy).
    Treatment is considered to have clinical feasibility if DLT as defined in the protocol in chapter 13.2 will not be observed, and no non-acceptance by the patient leading to premature withdrawal, and no death due to cancer or cancer therapy will occur.
    E.2.2Secondary objectives of the trial
    To determine and compare the drug delivery between both treatment arms
    To determine the Time To Treatment Failure (TTTF)
    To determine the Relapse Free Survival (RFS)
    To determine the Overall Survival (OS)
    To determine the Distant Metastases Free Survival (DMFS)
    To determine the Local Relapse Free Survival (LRFS)
    To determine the Localization of Relapse
    To determine Dose Delivery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC), pathologic stage IB, IIA, IIB or T3N1 (without need for further radiotherapy)

    Complete tumor resection without detectable residual tumor including negative margins (R0) [R-classifaction according to Wittekind et al 2002] and systematic intraoperative dissection of mediastinal lymph nodes according to the guidelines of the British thoracic society (British thoracic society, 2001; Hoffmann et al., 1999); of course lymph node dissection has to comprise all lymph node levels removed with standard right or left sided resection. The dissection has to assure the removal of mediastinal lymph nodes > 1,5 cm on the preoperative CT scan.

    The following histological tumor types are eligible:
    - Squamous Cell Carcinoma
    - Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation)
    - Large Cell Carcinoma (excluding tumors with slight areas of small cell carcinoma
    with neuroendocrine differentiation)
    - Mixed Cell Carcinoma without small cell fraction
    - Provision of informed consent according to local regulatory requirements for
    participation in the study
    - Age between 18 – 75 years
    - Karnofsky Performance Status ≥ 80% or ECOG performance status less or equal 1
    - Adequate hematological laboratory parameters
    - Hemoglobin ≥ 10 g/dl
    - ANC ≥ 1,500 /µl
    - Platelets ≥ 100000 /µl
    - Adequate hepatic laboratory parameters:
    - Bilirubin less or equal 1.5 x UNL
    - ASAT/ALAT less or equal 2 x UNL
    - Adequate renal laboratory parameters
    - Creatinine less or equal 1,5 mg/dl and
    - Calculated Creatinine Clearance ≥ 60 ml/min
    - Cardiac function allowing Cisplatin chemotherapy (in case of doubt
    echocardiography is mandatory documenting LVEF > 49%)
    - 12-lead Electrocardiogram without significant cardiac arrhythmia
    - FEV1 ≥ 1.2 l post-operatively
    - Respiratory function not impeding Cisplatin-based chemotherapy assessed by
    either absolute DLCO or capillary / arterial BGA in resting condition (absolute DLCO
    > 40 % or pO2 >60 mmHg in resting condition
    - Agreement by the patient to use an effective method of contraception
    - Negative pregnancy test for women of childbearing potential or women who are
    postmenopausal at baseline. (Postmenopausal women must have been
    amenorrheic at least for 12 month to be considered of non child-bearing potential)
    E.4Principal exclusion criteria
    - Presence of a Pancoasttumor
    - The following histological tumor types are excluded
    - Pure Bronchioloalveolar carcinoma
    - Mixed cell carcinoma with small cell fractions
    - Large cell carcinoma with areas of small cell carcinoma
    - Involvement of N2/N3 lymph nodes
    - Distant metastases
    - Pregnancy or lactation period
    - Other co-existing malignancies or malignancies diagnosed within the last 5 years
    with the exception of basal cell carcinoma of cervical cancer in situ or non-
    melanomatous skin cancer. Patients curatively treated and free of disease for at
    least 5 years will be discussed with the Principal Investigator (LKP) before inclusion
    - Radio- and/or chemotherapy within the last five years
    - Concurrent administration of any other antitumor therapy
    - Patients who are not compliant with vitamin (folic acid and vitamin B12) intake or to
    whom administration is not possible
    - Treatment with an investigational new drug, currently or within the last 30 days,
    and/or participation in another clinical trial, currently or during the last 12 weeks,
    and/or previous participation in this study
    - Patient has previously completed or withdrawn from this study or any other study
    with the respective medication in this study
    - History of a psychological illness or condition such as to interfere with the patient's
    ability to understand the requirements of the study
    - Patients with any clinically significant disease that in the opinion of the investigator
    is likely to put the patient at risk or to interfere with the evaluation of the patient's
    safety and of the study outcome. This includes, but is not limited to:
    - Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
    coronary artery disease and cardiac arrhythmia not well controlled with medication)
    or myocardial infarction within the last 6 months
    - Uncontrolled hypertension
    - Interstitial pneumonia, or extensive or symptomatic interstitial fibrosis of the lung.
    - Pleural effusion or ascites, which cause respiratory compromise. Patients with sero
    (pneumo)-thorax after hemi-pneumonectomy will not be excluded. Those patients
    must be monitored for toxicity closely.
    - Any other active or uncontrolled infection
    - Organ allografts
    - A serious concomitant systemic disorder (e.g. active infection including HIV) that in
    the opinion of the investigator would compromise the patient’s ability to complete
    the study
    - Post-operative complications or other surgery-related conditions that could
    interfere with a study participation
    - Patients with neurologic disorders
    - A history or presence of any CNS disorder or psychiatric disability judged by the
    Investigator to be clinically significant and/or interfering with compliance
    - Hearing function/tinnitus impeding chemotherapy with Cisplatin and/or Vinorelbine
    - Alcohol and/or drug abuse
    - Patient is unable to interrupt high dose salicylates (like aspirin) or other non-
    steroidal anti-inflammatory drugs (NSAID´s) for a 5-day period starting 2 days
    before administration of Pemetrexed (8-day period for long-acting agents such as
    piroxicam).
    - Patients who cannot be regularly observed for psychological, sociological,
    geographical reasons or other concomitant conditions not permitting adequate
    follow-up and compliance to the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The experimental therapy arm would be rated as unacceptable, if the
    actual feasibility rate (= 1 – withdrawal/DLT rate) was 65 % or lower.
    On the other hand, the therapy would be considered to be a promising
    candidate for further development (e.g. in a phase III trial), if the true
    feasibility rate amounted to 80% or more.
    Probability to accept the experimental therapy as well tolerable, in spite
    of a true feasibility rate of < 65% (i.e. withdrawal/DLT rate > 35%): 5%
    (type I error)
    Probability to reject the experimental therapy as not sufficiently feasible
    (<65%), although the true feasibility rate is promising (> 80%): 20%
    (type II error, corresponding to a power of 80%).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint for Feasibility is after End of Treatment (30 days after last
    study medication) after completion and/or correction of the according
    case report forms (Baseline, Treatment, End of Treatments, AEs, SAEs,
    DLT, Concomitant Mediation)
    E.5.2Secondary end point(s)
    Time to treatment failure will be measured as the time from surgery to
    the time the patient is withdrawn due to: adverse events, progressive
    disease/ relapse, death, failure to return, or refused treatment/did not
    cooperate/withdrew consent. The date of last dose of treatment will be
    used as the date of event in the case that PD was not recorded earlier.
    Relapse free survival (RFS) will be measured as the time from surgery to
    the time the patient is first recorded as having disease relapse, or the
    date of death if the patient dies due to causes other than disease
    progression.
    Distant metastasis free survival (DMFS) will be measured as the time
    from surgery to the time the patient is first recorded as having distant
    metastatic disease. Local relapse free survival (LRFS) will be measured
    as the time from surgery to the time the patient is first recorded as
    having local relapse.
    Survival will be measured as the time from surgery to the date of death
    or the last date the patient was known to be alive.
    To determine the Localization of Relapse
    Localization of Relapse will be determined by imaging studies initiated
    upon clinical suspicion and defines the organ where local or distant
    relapse is first detected.
    Dose delivery will be measured as the effectively delivered
    chemotherapy dose considering all reductions, omissions and withdrawn
    patients. It will be presented as mean and median and the percentage of
    the mean and median of the absolute intended dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint for Dose Delivery is at End of Treatment (30 days after last
    study medication) after completion and/or correction of the according
    case report forms (Baseline, Treatment, End of Treatments, AEs, SAEs,
    DLT, Concomitant Mediation)
    Timepoint for all other secondary end points is at End of study after
    completion and/or correction of all case report forms.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject randomized: 31-MAR-2010
    Last Subject last visit: 31-OCT-2013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 134
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 134
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-14
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