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

Fudan University

Status: Unknown

Conditions: De-escalation; Oropharyngeal Carcinoma

Treatments: Other: Toxicities reduced treatment; Other: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04012502

2019-OR001

Details and patient eligibility

About

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.

Enrollment: 83 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
• T1-2/N1-3M0（except T1N1M0 and single LN<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
• Age ≥18
• No prior anti-tumor treatment
• Karnofsky Performance Score (KPS)≥70
• Adequate blood supply
• Informed consent obtained

Exclusion criteria

• cannot take contrast-MRI imaging
• Pregnant
• Combined with other malignant tumor (except basal cell carcinoma of skin)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

conventional treatment arm

Active Comparator group

Description:

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)

Treatment:

Other: conventional treatment

Toxicities reduced treatment arm

Experimental group

Description:

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)

Treatment:

Other: Toxicities reduced treatment