NIPH Clinical Trials Search

JRCT ID: jRCT1041220029

Registered date:10/06/2022

Induction chemotherapy for HPV positive oropharyngeal cancers (HIPPOCRATES)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedHuman papillomavirus-associated oropharyngeal cancers
Date of first enrollment07/10/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)The treatment starts with neoadjuvant chemotherapy with docetaxel plus cisplatin and 5-fluorouracil (TPF-NAC). If the patient exhibits sufficient response for a minimally invasive surgery, the patients will be scheduled for minimally invasive surgery. Postoperative radiotherapy or chemoradiotherapy is performed only if histological examination of the surgical specimens reveals high risk features.


Primary OutcomePathological complete response rate
Secondary OutcomeSafety of TPF-NAC, Surgery-related complications,Proportion of minimally invasive surgery without free-flap reconstruction, Proportion of adjuvant radiotherapy or chemoradiotherapy, Progression free survival, Overall survival, QOL score(EORTC QLQ-C30,QLQ-HN43)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 70age old
Include criteria1) Patients with histologically proven HPV-positive OPSCC. HPV positivity is defined as positivity for p16 immunohistochemistry on biopsy specimens 2) 20 - 74 years old at the time of gained for informed consent 3) ECOG PS0-1 4) T1N1-3M0,or T2-3NanyM0 status according to the 8th Editions of the Union for International Cancer Control 5) Both primary lesion and regional lymph node metastasis are initially resectable at baseline. However, if upfront surgery is performed, it is estimated that at least one of the following scenarios would occur: (i) invasive surgery, such as a reconstruction technique after resection and radical neck dissection,would be required (ii) suspicion of extranodal extension by computed tomography(CT)or magnetic resonance imaging(MRI) (iii) a positive or close surgical margin estimated in a large primary tumor (iv) the involvement of multiple regional lymph nodes 6) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval, or for radical endoscopic resection for head and neck cancer or esophageal cancer 7) Adequate functioning of major organ systems 8) Subjects gained consent in writing for participation of this study
Exclude criteria1) Has a diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer, curatively resected in situ breast cancer, and curatively resected in situ esophageal cancer 2) With severe infection 3) Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) 4) Women who are pregnant, contemplating pregnancy or amid breast-feeding 5) Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 6) Patients requiring systemic steroids medication 7) Uncontrolled diabetes mellitus 8) Has a history of severe emphysema or noninfectious pneumonitis 9) With Rouviere lymph node or supraclavicular lymph node metastasis 10) With distant organ metastases

Related Information


Public contact
Name Tomoya Yokota
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center
Scientific contact
Name Tomoya Yokota
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center