Oropharyngeal cancer MedDRA version: 18.1 Level: PT Classification code 10031096 Term: Oropharyngeal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Platinol, Platinol-AQ
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cisplatin
CAS Number: 15663-27-1
Other descriptive name: cis
Sponsors
Velindre NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 99
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;Primary 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. Fi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 ;Timepoint(s) of evaluation of this end point: Patients will continue clinical follow-up for at least 5 years as per standard of care. | — |
Countries
United Kingdom
Contacts
Public ContactChris Hurt
Wales Cancer Trials Unit
Outcome results
None listed