Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)


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Trial ID: NCT02215265


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.

Official Title

A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

Stanford Investigator(s)

Chris Holsinger, MD, FACS
Chris Holsinger, MD, FACS

Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Michelle M. Chen, MD, MHS
Michelle M. Chen, MD, MHS

Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)


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.


drug: Cisplatin

radiation: Postoperative radiotherapy


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nikita Bedi
+1 650-723-5957

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