Induction chemotherapy for HPV positive oropharyngeal cancers (HIPPOCRATES)

JRCT ID: jRCT1041220029

Registered date:10/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Human papillomavirus-associated oropharyngeal cancers
• Date of first enrollment: 07/10/2022
• Target sample size: 30
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Pathological complete response rate
• Secondary Outcome: Safety 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Yokota Tomoya
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development