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    Summary
    EudraCT Number:2014-003392-32
    Sponsor's Protocol Code Number:PATHOS-2014/VVC/0014
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-11-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003392-32
    A.3Full title of the trial
    A Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)-positive oropharyngeal cancer
    Eine Phase-III-Studie mit einer risikostratifizierten, adjuvanten Behandlung mit verminderter Intensität bei Patienten, die sich einer transoralen Operation für Humane Papillomavirus (HPV)-positive Oropharynxkarzinome unterziehen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate reduced intensity post-operative treatment for HPV positive throat cancer
    Das Ziel der Studie ist es zu untersuchen, ob man bei Humanen Papillomavirus (HPV) verursachte Krebserkrankungen des Mundrachens die unterstützende (adjuvante) Behandlung nach der Tumorentfernung reduzieren kann.
    A.3.2Name or abbreviated title of the trial where available
    Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)
    Post operative adjuvante Behandlung für HPV-positive Tumore
    A.4.1Sponsor's protocol code numberPATHOS-2014/VVC/0014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02215265
    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 SponsorVelindre NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 Krebshilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinik und Poliklinik für HNO Heilkunde
    B.5.2Functional name of contact pointProf. Susanne Wiegand
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstraße 10-14
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number0341 97 21 945
    B.5.5Fax number0341 97 21 709
    B.5.6E-mailSusanne.Wiegand@medizin.uni-leipzig.de
    B.Sponsor: 2
    B.1.1Name of Sponsor
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Cisplatin
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameCisplatin
    D.3.4Pharmaceutical form Concentrate 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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive namecis diamminedi- chloroplatinum (II)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Carboplatin
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCarboplatin
    D.3.4Pharmaceutical form Concentrate 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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Oropharyngeal cancer
    Oropharynxkarzinome
    E.1.1.1Medical condition in easily understood language
    Throat cancer
    Kopf-Hals-Tumoren
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031096
    E.1.2Term Oropharyngeal 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
    The aim of the PATHOS study is to assess whether swallowing function can be improved following transoral resection of HPV-positive Oropharyngeal cancer (OPSCC), by reducing the intensity of adjuvant (postoperative) treatment protocols, either by giving a lower dose of radiotherapy or by giving radiotherapy without chemotherapy.
    Ziel der Studie ist es, festzustellen, ob eine Verringerung der Intensität der adjuvanten Behandlung, entweder durch eine Reduktion der Dosis der Strahlentherapie oder durch den Wegfall der Chemotherapie, zu einer besseren langfristigen Schluckfunktion führt.
    E.2.2Secondary objectives of the trial
    Swallowing panel including qualitative and quantitative swallowing assessments
    Quality of life
    Acute and late toxicity
    Disease Free Survival
    Locoregional control
    Distant Metastases
    Schluckuntersuchungen für qualitative und quantitative Schluckbewertungen
    Lebensqualität
    Akut- und Spättoxizität
    krankheitsfreies Überleben
    lokoregionale Kontrolle
    Fernmetastasen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed or suspected squamous cell carcinoma of the oropharynx.
    • UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease. [Staging should be based on cross sectional imaging investigations carried out within 10 weeks of study entry].
    • Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection.
    • Patients considered fit for surgery and adjuvant treatment by the local MDT.
    • Aged 18 or over.
    • Written informed consent provided.
    • Histologisch bestätigtes oder vermutetes Plattenepithelkarzinom des Oropharynx
    • Erkrankung gemäß UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (oder UICC TNM 8th edition stage T1-T3, N0-N1). [Staging basierend auf bildgebenden Querschnittsuntersuchungen durchgeführt innerhalb von 10 Wochen nach Studienbeginn].
    • Entscheidung von lokalen Teams, dass der Patient sich einer Operation unterziehen müsse, um den primären Tumor und Halslymphknoten zu entfernen.
    • Patienten, deren Gesundheitszustand eine Durchführung der geplanten Operation und der adjuvanten Radiotherapie zulässt
    • Alter ≥ 18 Jahren
    • Unterschriebene Einwilligungserklärung
    E.4Principal exclusion criteria
    • HPV negative squamous cell carcinomas of the head and neck.
    • T4 and/or T1-T3 tumours where transoral surgery is considered not feasible.
    • UICC/AJCC TNM 7th edition N2c-N3 nodal disease (or UICC/AJCC TNM 8th edition N2-N3 nodal disease).
    • Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
    • Current smokers with N2b disease (including smokers up to 6 months before diagnosis), even if HPV-positive. Vaping is permitted and should be considered as non-smoking status.
    • Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction prior to index oropharyngeal cancer.
    • Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.
    • History of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
    • Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.
    • HPV-negative Plattenepithelkarzinome des Kopf-Hals-Bereichs
    • T4 und/oder T1-T3 Tumore, bei denen eine transorale Chirurgie als nicht durchführbar angesehen wird.
    • Lymphknotenstatus N2c-N3 gemäß UICC/AJCC TNM 7th edition N2c-N3 (oder N2-N3 gemäß UICC/AJCC TNM 8th Edition)
    • Patienten für welche eine transorale Chirurgie und Neck Dissection nicht als primäre Behandlungsmethode angesehen wird.
    • Aktive Raucher mit N2b Erkrankung (inbegriffen sind Patienten, die bis zu 6 Monaten vor Diagnose geraucht haben), auch wenn sie HPV-positiv sind. Dampfen (elektronische Zigaretten) ist gestattet und gilt als Nichtrauchen.
    • Jegliche bereits vorhandene medizinische Einschränkung, die die Schluckfunktion beeinträchtigt und / oder eine Schluckstörung, die vor der Diagnose des oropharyngealer Krebses vorangegangen war.
    • Fernmetastasen, die bei dem routinemäßigem pre-operativem Staging, z.B. CT Thorax und oberes Abdomen oder PET-CT, festgestellt werden.
    • Andere Malignome in den letzten 5 Jahren, außer kurativ Basaliom der Haut oder in situ Zervixkarzinom
    • Schwangere oder stillende Frauen und Frauen im gebärfähigen Alter ohne hochwirksame Empfängnisverhütung
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the PATHOS study are swallowing function as measured by the MD Anderson Dysphagia Inventory (MDADI), 12 months after treatment and overall survival.
    Die primären Endpunkte der PATHOS-Studie sind die Schluckfunktion, gemessen mit dem MD Anderson Dysphagia Inventory (MDADI), 12 Monate nach der Behandlung und das Gesamtüberleben.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve months was chosen as the primary endpoint to evaluate long-term swallowing outcomes because longitudinal data show that functional recovery occurs primarily within 12 months, with little change in swallowing outcomes from 12 to 24 months.
    Der Zeitpunkt zwölf Monate wurden für den primären Endpunkt gewählt, um langfristige Schluckergebnisse zu bewerten, da Längsschnittdaten zeigen, dass die funktionelle Erholung vor allem innerhalb von 12 Monaten erfolgt, wobei sich die Schluckergebnisse von 12 bis 24 Monaten kaum ändern.
    E.5.2Secondary end point(s)
    The secondary end-points are:
    • Swallowing panel measurements including qualitative and quantitative swallowing assessments.
    • Quality of Life (using EORTC QLQ C30 and HN35 questionnaires.
    • Acute and late toxicity measured using CTCAE V4.03 scoring criteria.
    • Disease free survival, locoregional control, distant metastasis

    Sekundäre Endpunkte sind:
    • Schluckpanelmessungen einschließlich qualitativer und quantitativer Schluckbewertungen
    • QOL (EORTC QLQ C30 und HN35)
    • Akut- und Spättoxizität (CTCAE v4.03)
    • krankheitsfreies Überleben,
    • Lokoregionale Kontrolle und Fernmetastasen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will continue clinical follow-up for at least 5 years as per standard of care.
    Patients will continue clinical follow-up for at least 5 years as per standard of care.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    Radiotherapie
    radiotherapy
    E.8.2.4Number of treatment arms in the trial5
    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 concerned10
    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 No
    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
    The end of the trial is defined as the date of final data capture to meet the trial endpoints.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state90
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1169
    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)
    Clinical follow-up (for disease recurrence) should follow National guidelines and continue for (at least) 5 years after treatment.

    Treatment for recurrence shall be in accordance with standard of care.
    Die Behandlung in der Nachbeobachtung (im Falle eines Rezidiv des Tumors) entspricht der Standardbehandlung mindestens 5 Jahre nach der Studienbehandlung.
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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