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    Summary
    EudraCT Number:2014-003392-32
    Sponsor's Protocol Code Number:2014/VCC/0014
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-08-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-003392-32
    A.3Full title of the trial
    A Phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)-positive oropharyngeal cancer
    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
    A.3.2Name or abbreviated title of the trial where available
    Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)
    A.4.1Sponsor's protocol code number2014/VCC/0014
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWales Cancer Trials Unit
    B.5.2Functional name of contact pointChris Hurt
    B.5.3 Address:
    B.5.3.1Street AddressCardiff University, 6th Floor, Neuadd Meirionnydd
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCF14 4YS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number029 206 87471
    B.5.5Fax number029 206 87501
    B.5.6E-mailhurtcn@cf.ac.uk
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Platinol, Platinol-AQ
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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/m2 milligram(s)/square meter
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oropharyngeal cancer
    E.1.1.1Medical condition in easily understood language
    Throat cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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.

    The phase II study will also determine the feasibility of recruitment in the UK – if it is successful, it will progress to a larger phase III study to prove that cancer control rates and survival are maintained when the intensity of treatment is reduced.
    E.2.2Secondary objectives of the trial
    Standardising transoral surgery for the treatment of OPSCC.

    Providing participating surgeons with accreditation.

    Ensure surgical margin assessment after transoral resection of OPSCC is standardised by central pathology review of all specimens.

    Develop a standardised swallowing assessment tool for patients undergoing treatment for OPSCC which can be utilised by Speech and Language Therapists (SLTs) in centres around the UK.

    Develop a National Radiotherapy Trials Quality Assurance (RTTQA) package and adjuvant Intensity Modulated Radiotherapy (IMRT) protocol for the post-operative management of OPSCC.

    Develop a programme of research to use the clinical samples collected during the PATHOS trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx.
    • HPV positive on central testing.
    • UICC TNM (7th edition) stage T1-T3, N0-N2b tumours of the oropharynx. Staging should be based on cross sectional imaging investigations carried out within 6 weeks of study entry*.
    • Local 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.
    * Please Note: Current smokers with N2b disease (including smokers up to 2 years before diagnosis) are not eligible to be included.
    E.4Principal exclusion criteria
    • HPV negative squamous cell carcinomas of the head and neck.
    • Patients with T4 primary oropharyngeal tumours and/or T1-T3 tumours where transoral surgery is considered not feasible.
    • N2c-N3 nodal disease.
    • Unresectable retropharyngeal node involvement.
    • Current smokers with N2b disease (including smokers up to 2 years before diagnosis).
    • Any pre-existing medical condition likely to impair swallowing function and/ or a history of pre-existing swallowing dysfunction.
    • Patients with distant metastatic disease (UICC TNM stage IVC disease) as determined by routine pre-operative staging radiological investigations e.g., CT thorax and upper abdomen or PET-CT.
    • Patients with a history of malignancy in the last 5 years, except basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
    • Pregnant or lactating women and fertile women who will not be using contraception during the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the PATHOS phase II study will be swallowing function, measured using the MD Anderson Dysphagia Inventory (MDADI) at 12 months post-treatment.

    The MDADI is a patient-reported swallowing outcome measure, specifically designed for the head and neck cancer population. The 20-item written questionnaire has proven reliability and validity, and is sensitive to changes over time. MDADI scores also follow the expected pattern of recovery after organ preservation regimens for head and neck cancer and can differentiate between distinct cancer treatment regimes. Each item on the MDADI follows a five-point response scale. Five scores can be calculated from the MDADI including 2 summary scores (global, total/composite) and 3 subscales (emotional, functional, physical) each calculated as a weighted average with a range of 20 (worst impairment) to 100 (no impairment). The 19-item total (or composite) score was chosen as the primary endpoint of PATHOS because it summarizes overall impairment on the basis of physical, functional, and emotional domains. Between-group differences in the composite score have also been shown to differentiate clinically relevant conditions of swallowing function (i.e. aspiration, feeding tube dependence, and dietary restrictions).

    The primary outcome of the proposed phase III study will be overall survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the phase II study twelve months was chosen for the primary endpoint to assess long-term swallowing outcomes as longitudinal data demonstrates that most functional recovery is observed at 12 months, with little change in swallowing outcomes from 12 to 24 months.
    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.
    • Overall survival, disease free survival, locoregional control, distant metastasis

    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.
    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) Yes
    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
    radiotherapy
    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 concerned30
    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 years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days20
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state242
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 242
    F.4.2.2In the whole clinical trial 242
    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.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation South East Wales Research Network, NISCHR
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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