Oropharyngeal cancer MedDRA version: 20.0 Level: PT Classification code 10031096 Term: Oropharyngeal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Other descriptive name: cis diamminedi- chloroplatinum (II)
Con
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
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 radiotherapy. - Aged 18 or over. - Patients must be affiliated to a Social Security System. - Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent. - Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 726 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 374
Exclusion criteria
Exclusion criteria: - Known 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. - Persons deprived of their liberty or under protective custody or guardianship. - Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate if swallowing function can be improved and toxicities reduced following transoral surgery for HPV-positive oropharyngeal cancer, by reducing the intensity of adjuvant treatment protocols. 2. To demonstrate the non-inferiority of reducing the intensity of adjuvant treatment protocols in terms of overall survival;Secondary Objective: 1. Standardisation of transoral surgery for OPSCC by rigorous application of surgical standards. 2. The credentialing of participating surgeons. 3. Standardisation of surgical margin assessment after transoral surgery and examination of the clinical-pathological correlates of HPV-positive OPSCC by central pathology review of specimens. 4. Development of a standardised, multi-faceted swallowing assessment tool for patients undergoing treatment for OPSCC, applicable by Speech and Language Therapists (SLTs) in multiple centres. 5. Development of a RTTQA package and adjuvant Intensity Modulated Radiotherapy (IMRT) protocol for OPSCC. Dose/volume data for swallowing structures will be recorded so that the relationship between long-term swallowing function (phase II endpoint) and dose/volumes received by the swallowing organs can be prospectively analysed. 6. A programme of translational research will be developed to utilize PATHOS clinical samples.;Primary end point(s): Overall survival swallowing function as measured by the MD Anderson Dysphagia Inventory (MDADI) score;Timepoint(s) of evaluation of this end point: at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Swallowing panel measurements including qualitative and quantitative swallowing assessments - QOL (using EORTC QLQ C30 and HN35 questionnaires). - Acute and late toxicity, assessed using NCI CTCAE criteria version 4.03. - Overall survival, disease free survival, locoregional control, distant metastases.;Timepoint(s) of evaluation of this end point: Assessments take place at baseline (before surgery), 4 weeks post surgery and then at 1, 6, 12 and 24 months after adjuvant therapy | — |
Countries
Australia, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactProject Manager
UNICANCER
Outcome results
None listed