Trials / Unknown
UnknownNCT03908372
Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma
A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
Detailed description
The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed. The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.
Conditions
- Stage II, III
- Nasopharyngeal Squamous Cell Carcinoma
- Induction Chemotheray
- Concurrent Chemoradiotherapy
- Reduce Treatment Intensity
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles |
| DRUG | Cisplatin | Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy |
| RADIATION | IMRT | IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx. |
Timeline
- Start date
- 2019-06-15
- Primary completion
- 2021-05-01
- Completion
- 2025-05-01
- First posted
- 2019-04-09
- Last updated
- 2021-01-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03908372. Inclusion in this directory is not an endorsement.