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    Summary
    EudraCT Number:2010-021139-15
    Sponsor's Protocol Code Number:ESC-928-MOL-0000-I
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-06-28
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021139-15
    A.3Full title of the trial
    Do Selective Radiation Dose Escalation and Tumor Hypoxia Status Impact the Locoregional Tumor Control after Radiochemotherapy of Head & Neck Tumors?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Do Selective Radiation Dose Escalation and Tumor Hypoxia Status Impact the Locoregional Tumor Control after Radiochemotherapy of Head & Neck Tumors?
    A.3.2Name or abbreviated title of the trial where available
    ESCALOX
    A.4.1Sponsor's protocol code numberESC-928-MOL-0000-I
    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 SponsorTechnische Universität München Fakultät für Medizin
    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 supportDeutsche Forschungsgesellschaft DFG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMünchner Studienzentrum
    B.5.2Functional name of contact pointDr. Sabine Barta
    B.5.3 Address:
    B.5.3.1Street AddressIsmaninger Str.22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941407787
    B.5.5Fax number00498941407787
    B.5.6E-mailsabine.barta@mri.tum.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 18F-FMISO
    D.2.1.1.2Name of the Marketing Authorisation holderIASON Austria
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 name[18F]-FMISO
    D.3.4Pharmaceutical form Injection
    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 INNMISONIDAZOLE
    D.3.9.1CAS number 13551-87-6
    D.3.9.4EV Substance CodeSUB08997MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number740
    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 Yes
    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
    This study tests the hypothesis that the Radiation dose escalation to the macroscopic Tumor improves the locoregional control survival after concomitant chemoradiation over 2 years.

    As a translational objective the pre-therapeutic [18F]-FMISO PET Imaging of Tumor hypoxia is investigated as a useful croterion for stratification, especially with regard to prediction of improved locoregional Tumor control by dose escalation for further clinical studies.
    E.1.1.1Medical condition in easily understood language
    This study evaluates if an increase in radiation dose improves the control of the tumor and survival of the patients over 2 years
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Following the requirements of the Bundesamt für Strahlenschutz the primary objective of the pre-study is to assess the occurence of radiogenic toxicities.
    The main Escalox-trial hypothesizes an improvement in the 2-year loco-regional tumor control and survival in patients of explorative trial arm A in comparison to patients of arm B which undergo standard radiotherapy due to the use of Radiation dose escalation to a sub-volume of the gross tumor volume of locally advanced head and neck cancer in arm A. Primary objective: Does a selective radiation dose escalation to gross Tumor volume improve loco-regional control and survival over 2 years?
    E.2.2Secondary objectives of the trial
    The secondary objective of the main study is to assess survival, disease progression, toxicity and quality of life.
    In an subset of patients it is planned to assess the Signal stability of static pretherapeutic Imaging with 18F-FMISO PET Imaging, to assess by use of the additional acquisition of dynamic PET data ist accuracy regarding the identification of hypoxic Tumor sub-regions and patinet outcome, and to assess as a translational objective the pre-therapeutic 18-F-FMISO PET Imaging of Tumor hypoxia is investigated as a useful criterion for stratification, especially with regard to prediction of improved loco-regional Tumor control by dose escalation for further clinical studies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed written informed consent
    • Age ≥ 18 ≤ 70 years
    • Independent of gender
    • Independent of race
    • ECOG 0 – 2
    • Tumor of oral cavity,oropharynx or hypopharynx
    • Histology: squamous cell carcinoma
    • Curativ etreatment intended
    • Tumor is classified as irresectable (see Appendix)
    • Woman of child-bearing age: negative pregnancy testin serum
    • Contraception in male and female patients and their partners if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post therapy
    • Sufficient bone marrow reserves during 7 days before study inclusion; (leukocytes ≥ 4 x 109/l, absolute no. of neutrophiles (ANC) ≥ 2 x 109/; thrombocyte count ≥ 100 x 109/l; Hemoglobin ≥ 10g/dl)
    • adequate liver function during 7 days before study inclusion (total bilirubine ≤ 2,5 x ULN (upper limit of normal), ASAT/ ALAT ≤ 2,5 x ULN, alkaline phosphatase ≤ 2,5 x ULN of the institution’s normal value)
    • adequate kidney function during 7 days before study inclusion; serum creatinine ≤ 130 μmol/l; creatinine clearance ≥ 70 ml/min
    • all patients should have a dental examination before starting therapy and when necessary be treated, adaptation of a teeth protection bar
    • a percutane feeding tube should be applied before start of treatment
    E.4Principal exclusion criteria
    Patients are not eligible for this study if they fulfill one or more of the following exclusion criteria:
    • Infiltration of the mandible and / or larynx
    • impaired renal and/ or liver function
    • secondary malignancy, unknown primary cancer, nasopharynx cancer or salivary gland cancers
    • Metastatic disease
    • Another cancer within 5 years of study entry
    • Serious concomitant disease or medical condition
    • Pregnancy or lactation
    • Women of child-bearing potential with unclear contraception (post menopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential)
    • previous treatment with chemotherapy, radiotherapy or surgery in head and neck (except an excisional biopsy or biopsy for histology)
    • concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
    • life expectancy of < 1 year
    • contraindications to receive Cisplatin
    • social situations that limit compliance with study requirements
    E.5 End points
    E.5.1Primary end point(s)
    The primary toxicity endpoint of the pre-study the occurrence of radiaton induced toxicities reported regarding CTCAE 4.0.
    The primary efficacy endpoint of the main trial is the loco-regional control (LRC)-survival over two years. It is defined as the time to local relapse or death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary end point(s)
    • Overall Survival (OS) over 2 years
    • Progression-free Survival (PFS) over 2 years
    • Relapse-free Survival (RFS) over 2 years
    • Time to Progression (TTP) over 5 years
    • Occurrence of Distant Metastases (DM)
    • Acute and late toxicity esp. concerning salivary glands
    • Quality of life (EORTC, H&N 35)
    • Adverse effects according to NCI CTC-AE (VERSION 4.0/ 01/10/ 2010) and LENT-SOMA
    In a subset of patients, the following secondary endpoints will be assessed:
    • Mean amount of temporal shift of hypoxic areas (% overlap)
    • Static 18-F-FMISO PET parameters: hypoxic volume (HV), hypoxic fraction (HF), visual assessment (semiquantitative scoring), maximum tumour to blood activity ratio (T:Bmax), maximum tumour to muscle activity ratio (T:Mmax); each for single lesions (primary and cervical metastases) and total tumour mass.
    • Temporal shift of hypoxic volumes: total hypoxic volume (THV), overlapping hypoxic volume (OHV), non-overlapping hypoxic volume (N-OHV), ∆HV (HV1-HV2), ∆HF (HF1-HF2), ∆T:Bmax (T:Bmax(1)-T:Bmax(2)), ∆T:Mmax (T:Mmax(1)-T:Mmax(2)), ∆score (score1-score2); each for single lesions (primary and cervical metastases) and total tumour mass.
    • Correlation of in-field relapses with hypoxic areas: 1. oxygenated area, 2. non-overlapping hypoxic area, 3. overlapping hypoxic area.
    • Value of additional acquisition of dynamic PET data to improve the accuracy of static PET (e.g. Thorwarth model).

    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Control arm: GTV 70 Gy in comparison with experimental arm: DEV 80,5 Gy
    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 concerned14
    E.8.5The trial involves multiple Member States No
    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 No
    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 Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state270
    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)
    None
    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 Decision2010-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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