Clinical trial · Interventional
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| De-escalation | — | UNRESOLVED | — |
| Oropharyngeal Carcinoma | Oropharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional treatment | Other | — | UNRESOLVED |
| Toxicities reduced treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- conventional treatment arm
- 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)
- interventionNames
- Other: conventional treatment
- type
- EXPERIMENTAL
- label
- Toxicities reduced treatment arm
- 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)
- interventionNames
- Other: Toxicities reduced treatment
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDLyu W, Gong J, Zhu L, Xu T, Huang S, Shen C, Wang C, He X, Ying H, Hu C, Wang Y, Ji Q, Gu Y, Zhou X, Lu X. MR radiomics unveils neoadjuvant chemo-responsiveness with insights into selective treatment de-intensification in HPV-positive oropharyngeal carcinoma. Oral Oncol. 2024 Dec;159:107049. doi: 10.1016/j.oraloncology.2024.107049. Epub 2024 Sep 27. PMID 39341091