Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, De-escalation
Brief summary
The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.
Interventions
RADIATIONToxicities reduced treatment
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.
RADIATIONConventional treatment
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT. Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR). Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.
Sponsors
Chaosu Hu
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological diagnosis of nasopharyngeal carcinoma * Stage III or IVA 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
* Can not take contrast-MRI imaging * Pregnant * Combined with other malignant tumor (except basal cell carcinoma of skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 3 year | Disease Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3 year | Overall Survival |
Countries
China
Contacts
Primary ContactYouqi Yang, MD
Backup ContactXueguan Lu, MD
Outcome results
None listed