NCT04012502

De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations

De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.

Conditions

• Oropharyngeal Carcinoma
• De-escalation

Interventions

Type	Name	Description
OTHER	Toxicities reduced treatment	Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
OTHER	conventional treatment	Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-07-01
• Completion: 2020-12-31
• First posted: 2019-07-09
• Last updated: 2019-07-09

Locations

1 site across 1 country: China