De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
| Registry | NCT04012502 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, sequential, masking: none, treatment |
| Enrollment | 83 (Estimated) |
| Sponsor | Fudan University (Other) |
| Conditions | Oropharyngeal Carcinoma, De-escalation |
| Interventions | Toxicities reduced treatment, conventional treatment (Other) |
| Dates | start 2019-07-01, primary completion 2019-07-01, completion 2020-12-31 (estimated), first posted 2019-07-09, last updated 2019-07-09 |
| Locations | 1 site in China |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| conventional treatment arm | Active comparator | 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) |
| Toxicities reduced treatment arm | Experimental | 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) |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Centre | Shanghai, Shanghai Municipality | China | Recruiting |