Nasopharyngeal Carcinoma Clinical Trial
Official title:
A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
- To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs
radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of
the study includes : overall survival, relapse free survival, distant metastasis and
local-regional control rates.
- To evaluate the toxicities of the two treatment methods.
The head and neck contracts study tested induction and maintenance chemotherapy in patients
with advanced head and neck cancers.There were no significant differences in survival
between the two groups, but disease free survival was prolonged in the maintenance arm and
not in the induction arm. Time to and frequency of distant metastases as the first site of
relapse were significantly better for those on the maintenance arm. Many trials, designed
several years ago, delivered single agent chemotherapy and were not particularly intensive.
Most clinical trials were dealing with a heterogenous group of head and neck cancer
patients. We felt that a better choice of adjuvant chemotherapy on cancers should include:
(1) localized cancers with high metastatic potential following effective local treatment;
(2) effective chemotherapy available; (3) chemotherapy should be intensive and effective
enough to avoid the development of drug resistance. Of course, NPC had long been regarded as
one of the most suitable head and neck cancers that may benefit from adjuvant chemotherapy
due to its unique high response rate to chemotherapy and high metastatic potential after
radiotherapy for localized, advanced staged disease.
If radiotherapy plus adjuvant chemotherapy can improve the treatment results of standard
radiotherapy by increasing the survival rate, decreasing the metastatic rate and local
recurrence rate, then many NPC patients may benefit.
Therefore, we propose this phase III study of radiotherapy with or without adjuvant PFL
chemotherapy in advanced stage NPC patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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