- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02215265
Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS) (PATHOS)
A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer
The main objectives of the PATHOS study are:
To assess whether swallowing function can be improved following transoral resection of HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to personalise treatment, based on disease biology (HPV status and pathology findings), to optimise patient outcomes.
To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival in the reduced intensity treatment arms.
Study Overview
Status
Intervention / Treatment
Detailed Description
PATHOS is a multicentre, open-label, parallel-group Phase II/III randomised controlled trial (RCT). The phase II target of 242 patients was reached in December 2018 and there was a seamless transition into Phase III. The protocol was amended in September 2018 to incorporate the changes associated with the phase III transition. The amendment included changes to the outcome measures and sample size calculations.
Approximately 1100 patients will be recruited to the phase III study. Patients eligible for the study must have biopsy proven oropharyngeal squamous cell carcinoma (OPSCC) clinically staged T1T3 N0N2b. Their primary tumour, as judged by the local MDT, must be considered resectable via a transoral approach. Having secured informed consent, patients with centrally or locally determined HPV positive tumours will undergo baseline assessment of swallowing function (includes; MDADI score, videofluoroscopy, PSSH& N, 100 mL water swallow test) and complete QOL questions (EORTC QLQC30 and EORTC QLQH&N35) prior to surgery.
Transoral Laser Microsurgery, Transoral Robotic Surgery & Endoscopically assisted Transoral Surgery are all accepted transoral techniques for the study. A lateral oropharyngectomy performed with monopolar cautery (The Huet Procedure) can also be used.
Following surgery and histopathological assessment of the primary tumour and neck dissection surgical specimens, participants will be allocated into study groups based on the presence or absence of pathological risk factors for recurrence as follows:
Group A: Participants with tumours which exhibit no adverse histological features. Participants in this group will not receive any adjuvant treatment as per standard of care.
Group B: Participants with T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour. Patients in this group will be randomised to PORT 60Gy in 30# over 6 weeks (Control Arm B1) or PORT 50Gy in 25# over 5 weeks (Test Arm B2).
Group C: Participants with tumours of any T or any N stage, which exhibit the following high-risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease. Participants in this group will be randomised to POCRT 60Gy in 30# over 6 weeks with concurrent Cisplatin (Control Arm C1) or PORT 60Gy in 30# over 6 weeks without chemotherapy (Test Arm C2).
Participants in groups B and C will be stratified before randomisation by T stage, N stage, smoking history and treating centre.
The same assessments as at baseline will be completed post-operatively prior to treatment and then at four weeks and 6, 12 and 24 months post-treatment. The exception is videofluoroscopy which will be repeated at post-surgery and 12 months only. Videofluroscopies are only performed at UK sites.
Acute and late toxicity will be recorded weekly during treatment and again at 4 weeks and 6, 12 and 24 months post-treatment.
All study assessments, complications relating to surgery and adjuvant treatment, in particular complications which necessitate a delay to the start of adjuvant treatment, will all be recorded on the Case Report Form (CRF).
International sites have been initiated on Electronic Data Capture (EDC) and local UK sites have transitioned to EDC for participants enrolled after implementation. Data entry needs to be completed within four weeks of the study visit. In accordance with the principles of GCP, the PI is responsible for ensuring accuracy, completeness, legibility and timeliness of the data reported to the CTR in the CRFs. The CRF will be checked for missing, illegible or unusual values (range checks) and consistency over time.
If missing or questionable data are identified, a data query will be raised on a data clarification form and sent to the site for resolution. All answered data queries and corrections should be signed off and dated by a delegated member of staff at the relevant participating site.
The CTR will send reminders for any overdue data. It is the site's responsibility to submit complete and accurate data in a timely manner.
Quality assurance: The clinical trial risk assessment has been used to determine the intensity and focus of central and on-site monitoring activity in the PATHOS trial. Monitoring levels will be employed and are fully documented in the trial monitoring plan. Investigators should agree to allow trial-related monitoring, including audits and regulatory inspections, by providing direct access to source data/documents as required. Patient consent for this will be obtained.
Registration: All sites have transitioned to an electronic database and the registration and randomisation process is completed online. Participants will be randomised using minimisation with a random element. This will ensure balanced treatment allocation by clinically important stratification factors. Randomisation will have an allocation ratio of 1:1.
Statistical analyses:
Primary outcome measure
MDADI/Overall survival co-primary endpoint
Secondary outcome measures
- Swallowing panel including qualitative and quantitative swallowing assessments (100ml Water Swallow Test, Videofluoroscopy, Performance Status Scale-Head & Neck)
- QOL (using validated EORTC QLQ C30 and HN35 questionnaires, Appendix 6)
- Acute and late toxicity using CTACE version 4.03
- Disease-Free Survival*
- Locoregional control*
- Distant Metastases* *Determined by clinical follow-up as per standard guidelines (no trial-specific imaging required)
The co-primary endpoint of the Phase III will be MDADI and overall survival (time to event).
We will use linear regression to estimate the treatment arm effect on MDADI at 12 months and will include the randomisation stratification variables and baseline MDADI in the model. Both OS and MDADI endpoints will be used to define study success so no adjustment for multiplicity is planned. A detailed statistical analysis plan will be developed before the analyses are conducted.
The data will be reviewed (approximately six-monthly) by an Independent Data Monitoring Committee (IDMC), consisting of at least two Clinicians (not entering patients into the trial) and an independent Statistician. The IDMC will be asked to recommend whether the accumulated data from the trial, together with results from other relevant trials, justifies continuing recruitment of further patients. A decision to discontinue recruitment, in all patients or selected subgroups, will be made only if the result is likely to convince a broad range of Clinicians including PIs in the trial and the general clinical community. If a decision is made to continue, the IDMC will advise on the frequency of future reviews of the data based on accrual and event rates.
Sub-group statistical analyses:
For swallowing endpoints, subgroup analysis by T stage and tumour subsite (tonsil, soft palate, tongue base) and surgery technique will be carried out, as the most likely relevant clinical co-variables affecting swallowing function.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Brisbane, Australia, QLD 4113
- Recruiting
- Metro South Health
-
Contact:
- Ben Panizza, Prof
- Email: ben@panizza.com.au
-
-
-
-
-
Paris, France, 75013
- Recruiting
- UNICANCER
-
Principal Investigator:
- Florence Huguet
-
Contact:
- Haitham Mirghani (National Coordinator)
- Email: haitham.mirghani@aphp.fr
-
Principal Investigator:
- Pierre Blanchard
-
Principal Investigator:
- Vincent Gregoire
-
Principal Investigator:
- Franchel-Rais Obongo-Anga
-
Principal Investigator:
- Ovidiu Veresezan
-
Principal Investigator:
- Wassila Boukhelif
-
Principal Investigator:
- Alexandre Villeneuve
-
Principal Investigator:
- Sylvain MORINIERE
-
Principal Investigator:
- Guillaume Chambon
-
Principal Investigator:
- Philippe Ceruse
-
-
-
-
-
Berlin, Germany
- Recruiting
- Vivantes Klinikum
-
Contact:
- Volker Schilling
- Email: volker.schilling@vivantes.de
-
Hamburg, Germany
- Recruiting
- Asklepios Kliniken
-
Contact:
- Silke Tribius
- Email: silke@tribius.de
-
Leipzig, Germany
- Recruiting
- Universität Leipzig
-
Contact:
- Susanne Wiegand
- Email: Susanne.Wiegand@medizin.uni-leipzig.de
-
Principal Investigator:
- Silke Tribius
-
Potsdam, Germany
- Recruiting
- Ernst von Bergmann Klinikum
-
Contact:
- Markus Jungehulsing
- Phone Number: 0331/241-36007
- Email: mjungehuelsing@klinikumevb.de
-
Solingen, Germany, 42653
- Recruiting
- Städtisches Klinikum Solingen
-
Contact:
- A.M Sesterhenn
- Phone Number: 00492125472738
- Email: sesterhenn@klinikumsolingen.de
-
Ulm, Germany
- Recruiting
- Universitätsklinikum Ulm
-
Contact:
- Simon Laban
- Phone Number: 0731 500 59543
- Email: Simon.laban@uniklinik-ulm.de
-
-
-
-
-
Bath, United Kingdom, BA1 3NH
- Recruiting
- Royal United Hospitals Bath NHS Foundation Trust
-
Contact:
- Emma De Winton, Dr
- Email: emma.dewinton@nhs.net
-
Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital
-
Contact:
- Andrew Hartley, Dr
- Email: andrew.hartley@uhb.nhs.uk
-
Blackburn, United Kingdom, BB2 3HH
- Recruiting
- Royal Blackburn Hospital
-
Contact:
- Panayiotis Kyzas, Mr
- Email: Panayiotis.Kyzas@elht.nhs.uk
-
Brighton, United Kingdom, BN2 5BE
- Recruiting
- Royal Sussex County Hospital
-
Contact:
- Katy Bradley
- Phone Number: 63911 01273 696955
- Email: katy.bradley2@nhs.net
-
Principal Investigator:
- Katy Bradley
-
Bristol, United Kingdom, BS2 8ED
- Recruiting
- University Hospitals Bristol NHS Foundation Trust
-
Contact:
- Matthew Beasley, Dr
- Email: Matthew.Beasley@UHBristol.nhs.uk
-
Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- Cambridge University Hospitals NHS Foundation Trust
-
Contact:
- Irune Ekpemi, Miss
- Email: ekpemi.irune@addenbrookes.nhs.uk
-
Canterbury, United Kingdom
- Recruiting
- Kent and Canterbury Hospital
-
Contact:
- Robert Hone
- Email: rhone@nhs.net
-
Cardiff, United Kingdom, CF14 4XN
- Not yet recruiting
- HPV Research Group Section of Pathology Cardiff University ,School of Medicine
-
Contact:
- Ned Powell, Dr
- Email: PowellNG@cardiff.ac.uk
-
Cardiff, United Kingdom, CF14 4XW
- Recruiting
- Cardiff and Vale University Local Health Board
-
Contact:
- Sandeep Berry, Mr
- Email: Sandeep.Berry@wales.nhs.uk
-
Cardiff, United Kingdom, CF14 4YS
- Not yet recruiting
- Centre for Trials Research
-
Contact:
- Chris Hurt
- Phone Number: 02920687471
- Email: HurtCN@cardiff.ac.uk
-
Cardiff, United Kingdom, CF142TL
- Recruiting
- Velindre NHS Trust
-
Contact:
- Mererid Evans, Professor
- Email: Mererid.Evans@wales.nhs.uk
-
Cottingham, United Kingdom, HU16 5JQ
- Recruiting
- Castle Hill Hospital
-
Contact:
- Lorcan O'Toole, Dr
- Email: lorcan.otoole@hey.nhs.uk
-
Derby, United Kingdom, DE22 3DT
- Recruiting
- Derby Teaching Hospitals NHS Foundation Trust
-
Contact:
- Sean Mortimore, Mr
- Email: sean.mortimore@nhs.net
-
Edinburgh, United Kingdom, EH4 2XU
- Recruiting
- Western General Hospital
-
Contact:
- Iain Nixon, Mr
- Email: iain.nixon@nhs.net
-
Exeter, United Kingdom
- Recruiting
- Royal Devon University Health Care NHS Foundation Trust
-
Contact:
- Joel Smith
- Email: joel.smith2@nhs.net
-
Guildford, United Kingdom, GU2 7XX
- Recruiting
- Royal Surrey County Hospital
-
Contact:
- Stephen Derbyshire, Mr
- Email: stephen.derbyshire2@nhs.net
-
Leeds, United Kingdom, LS9 7TF
- Recruiting
- St James University Hospital
-
Contact:
- Kate Cardale, Dr
- Email: kate.cardale@nhs.net
-
Liverpool, United Kingdom, L3 9TA
- Recruiting
- Liverpool Head and Neck Centre
-
Contact:
- Terry Jones, Professor
- Email: T.M.Jones@liverpool.ac.uk
-
Liverpool, United Kingdom, L69 3GB
- Not yet recruiting
- University of Liverpool
-
Contact:
- Joanne Patterson, Prof
- Email: Joanne.Patterson@liverpool.ac.uk
-
Llantrisant, United Kingdom, CF72 8XR
- Recruiting
- Cwm Taf Bro Morganwg
-
Contact:
- Richard Webster, Dr
- Email: Richard.Webster@wales.nhs.uk
-
London, United Kingdom, NW1 2BU
- Recruiting
- University College London Hospitals NHS Foundation Trust
-
Contact:
- Jonathan Hughes, Mr
- Email: jonathan.hughes1@nhs.net
-
London, United Kingdom, SE1 9RT
- Recruiting
- Guys and St Thomas's NHS Foundation Trust
-
Contact:
- Asit Arora, Mr
- Email: Asit.Arora@gstt.nhs.uk
-
London, United Kingdom, SW17 0QT
- Recruiting
- St Georges University Hospital
-
Contact:
- Enyinnaya Ofo
- Phone Number: 0208 725 2052
- Email: enyinnaya.ofo@stgeorges.nhs.uk
-
London, United Kingdom, SW7 2AZ
- Recruiting
- Imperial College Healthcare NHS Trust
-
Contact:
- Zaid Awad, Mr
- Email: zawad@nhs.net
-
Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie NHS Foundation Trust
-
Contact:
- David Thomson, Dr
- Email: david.thomson@christie.nhs.uk
-
Manchester, United Kingdom, M13 9WL
- Recruiting
- Central Manchester University Hospital NHS Foundation Trust
-
Contact:
- Jarrod Homer, Professor
- Email: jarrod.j.homer@manchester.ac.uk
-
Manchester, United Kingdom, OL1 2JH
- Recruiting
- The Pennine Acute Hospital Trust
-
Contact:
- Kapil Java, Mr
- Email: kapil.java@mft.nhs.uk
-
Middlesbrough, United Kingdom, TS4 3BW
- Recruiting
- The James Cook University Hospital
-
Contact:
- Shane Lester, Mr
- Email: shanelester@nhs.net
-
Newcastle upon Tyne, United Kingdom, NE1 4LP
- Not yet recruiting
- Royal Victoria Infirmary
-
Contact:
- Max Robinson, Dr
- Email: max.robinson@nhs.net
-
Newcastle upon Tyne, United Kingdom, NE7 7DN
- Recruiting
- Newcastle upon Tyne Hospitals NHS Foundation Trust
-
Contact:
- James O'Hara, Mr
- Email: James.Ohara@nuth.nhs.uk
-
Newport, United Kingdom, NP18 3XQ
- Recruiting
- Aneurin Bevan University Health Board
-
Contact:
- Carl Passant, Mr
- Email: Carl.Passant@wales.nhs.uk
-
Nottingham, United Kingdom
- Recruiting
- Nottingham City Hospital
-
Contact:
- Neeraj Sethi
- Email: Neeraj.Sethi@nuh.nhs.uk
-
Oxford, United Kingdom, OX3 7LD
- Recruiting
- Oxford University Hospitals NHS Foundation Trust
-
Contact:
- Stuart Winter, Mr
- Email: stuart.winter@ouh.nhs.uk
-
Plymouth, United Kingdom, PL6 8DH
- Recruiting
- University Hospital Plymouth
-
Contact:
- Richard Williams, Mr
- Email: richard.williams8@nhs.net
-
Portsmouth, United Kingdom, PO6 3LY
- Recruiting
- Queen Alexandra Hospital
-
Contact:
- Costa Repanos, Mr
- Email: costa.repanos@porthosp.nhs.uk
-
Preston, United Kingdom, PR2 9HT
- Recruiting
- Royal Preston Hospital
-
Contact:
- Sharan Jayaram
- Phone Number: 01772522074
- Email: Sharan.ChakkyathJayaram@LTHTR.nhs.uk
-
Reading, United Kingdom, RG1 5AN
- Recruiting
- Royal Berkshire Hospital
-
Contact:
- Nicola Dallas, Dr
- Email: Nicola.Dallas@royalberkshire.nhs.uk
-
Southampton, United Kingdom, SO16 6YD
- Recruiting
- University Hospital Southampton
-
Contact:
- Satish Harinarayanan, Dr
- Email: sathish.harinarayanan@uhs.nhs.uk
-
Sunderland, United Kingdom, SR4 7TP
- Recruiting
- City Hospitals Sunderland NHS Foundation Trust
-
Contact:
- Helen Cocks, Dr
- Email: helen.cocks@chsft.nhs.uk
-
Swansea, United Kingdom, SA2 8QA
- Recruiting
- Swansea Bay University Local Health Board
-
Contact:
- Conor Marnane, Mr
- Email: conor.marnane@wales.nhs.uk
-
-
Dorset
-
Poole, Dorset, United Kingdom, BH15 2JB
- Recruiting
- University Hospitals Dorset NHS Foundation
-
Contact:
- Emma King, Dr
- Email: emmabarker@doctors.org.uk
-
-
-
-
California
-
Redwood City, California, United States, 94063
- Recruiting
- Board of Trustees of the Leland Stanford Junior University
-
Contact:
- Michelle Chen
- Phone Number: 650-723-5957
- Email: nbedi@stanford.edu
-
-
Florida
-
Orlando, Florida, United States, 32803
- Recruiting
- Advent Health
-
Contact:
- Bruce Haughey
- Phone Number: 407-303-0409
- Email: bruce.haughey.md@flhosp.org
-
Contact:
- Sara Guyler
- Phone Number: 1203655 407-543-4000
- Email: Sara.Guyler@AdventHealth.com
-
-
Texas
-
Houston, Texas, United States, 77030
- Active, not recruiting
- MD Anderson Cancer Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
- Multidisciplinary team (MDT) decision to treat with primary transoral resection and neck dissection.
- Patients considered fit for surgery and adjuvant radiotherapy
- Aged 18 or over.
- Written informed consent provided.
Exclusion Criteria:
- Known HPV negative squamous cell carcinomas of the head and neck: A negative result for p16 Immunohistochemistry automatically excludes a patient from the trial. If initial p16 testing is positive but High Risk HPV (HR HPV) In-Situ Hybridization (ISH)/Polymerase Chain Reaction (PCR) does not demonstrate the presence of HR HPV DNA, the patient will also be excluded. Patients who are p16+ may complete swallowing assessments, excluding videofluoroscopy, and surgery whilst HR HPV DNA status is being determined (with recourse to central concordance testing, if appropriate, for UK centres). HPV positivity, as determined by p16 and the demonstration of HR HPV DNA is essential before patients undergo videofluoroscopy or randomisation.
- 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 clinically staged 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.
- Patients with distant metastatic 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.
- Women who are pregnant or breastfeeding and fertile women who will not be using contraception during the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: A: No adjuvant treatment
Group A Patients with tumours which exhibit no adverse histological features.
Patients in this group will not receive any adjuvant treatment as per standard of care.
|
|
Active Comparator: B1: Postoperative radiotherapy 60 Gray
Arm B1: postoperative radiotherapy (PORT) at a dose of 60 Gray (Gy) in 30 fractions over 6 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour. |
Postoperative radiotherapy (PORT)
|
Experimental: B2: Postoperative radiotherapy 50 Gray
Arm B2: Postoperative radiotherapy (PORT) at a dose 50 Gray in 25 fractions over 5 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour. |
Postoperative radiotherapy (PORT)
|
Active Comparator: C1: Postoperative radiotherapy 60 Gray with Cisplatin
Arm C1: postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks with concurrent Cisplatin chemotherapy (POCRT). Cisplatin may be given 3 weekly (100mg/m2 week 1 and week 4 of radiotherapy) or weekly (40mg/m2 weekly during radiotherapy), according to local practice. Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease |
Postoperative radiotherapy (PORT)
Chemotherapy
|
Experimental: C2: Postoperative radiotherapy 60 Gray without chemotherapy
Arm C2: Postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks without chemotherapy (Test Arm C2). Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease |
Postoperative radiotherapy (PORT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MDADI/Overall survival co-primary endpoint
Time Frame: At 12 months following treatment measured using the MD Anderson Dysphagia Inventory (MDADI) score.
|
At 12 months following treatment measured using the MD Anderson Dysphagia Inventory (MDADI) score.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallowing panel including qualitative and quantitative swallowing assessments
Time Frame: Baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.
|
Water swallow test
|
Baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.
|
QOL (using validated EORTC QLQ C30 and HN35 questionnaires)
Time Frame: Baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.
|
Quality of Life (QOL) questions.
|
Baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.
|
Acute and late toxicity using CTACE version 4.03
Time Frame: Weekly during RT and at end of treatment; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks), 6 months (+/- 4 weeks), 12 months (+/- 4 weeks), and 24 months (+/- 8 weeks) post treatment.
|
Toxicity assessment
|
Weekly during RT and at end of treatment; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks), 6 months (+/- 4 weeks), 12 months (+/- 4 weeks), and 24 months (+/- 8 weeks) post treatment.
|
Disease Free Survival
Time Frame: 6 months intervals
|
Determined by clinical follow up as per standard guidelines
|
6 months intervals
|
Locoregional control
Time Frame: 6 months intervals
|
Determined by clinical follow up as per standard guidelines
|
6 months intervals
|
Distant Metastases
Time Frame: 6 months intervals
|
Determined by clinical follow up as per standard guidelines
|
6 months intervals
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mererid Evans, MBBch, PhD, Velindre NHS Trust
- Principal Investigator: Terrence Jones, MBBS,MD, Aintree University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/VCC/0014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)Active, not recruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Oropharyngeal Human Papillomavirus-Positive Squamous...United States
-
Jonsson Comprehensive Cancer CenterAstraZenecaTerminatedOropharyngeal Squamous Cell Carcinoma | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Pathologic... and other conditionsUnited States
-
Mayo ClinicRecruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Oropharyngeal Human Papillomavirus-Positive Squamous...United States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedHead and Neck Cancer | HPV (Human Papillomavirus)-Associated Carcinoma | OropharyngealUnited States
-
Gilead SciencesTerminatedHuman Papillomavirus (HPV) 16+ Relapsed/Refractory CancerUnited States
-
The University of Texas Health Science Center,...Baylor College of Medicine; Cancer Prevention Research Institute of TexasCompletedHuman Papillomavirus (HPV)United States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUnknownHuman Papillomavirus (HPV)United States
-
National Institute for Control of Vaccine and BiologicalsUnknownHuman Papillomavirus (HPV) VaccineVietnam
-
Jonathan Schoenfeld, MD, MPHNaverisRecruitingHPV Positive Oropharyngeal Squamous Cell Carcinoma | Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC... and other conditionsUnited States
-
University of FloridaPatient-Centered Outcomes Research Institute; National Cancer Institute (NCI)Not yet recruitingHuman Papillomavirus (HPV) VaccinesUnited States
Clinical Trials on Postoperative radiotherapy
-
Xiangyun ZongActive, not recruitingQuality of LifeChina
-
Cancer Institute and Hospital, Chinese Academy...Completed
-
Heinrich-Heine University, DuesseldorfNot yet recruiting
-
Cancer Institute and Hospital, Chinese Academy...CompletedThoracic Neoplasms | Non-small Cell Lung CancerChina
-
Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
-
University Hospital HeidelbergNot yet recruitingBrain Metastases | RadiotherapyGermany
-
University Medical Center GroningenRecruitingHead and Neck CancerNetherlands
-
Centre Jean PerrinGORTECActive, not recruitingHead and Neck NeoplasmsFrance
-
American College of RadiologyRTOG FoundationNot yet recruitingHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Larynx | Squamous Cell Carcinoma of the Oral Cavity | Squamous Cell Carcinoma of the Oropharynx
-
Susanne RogersUniversity of Basel; Technical University of MunichRecruitingBrain Metastases, AdultSwitzerland