Overview

Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chaosu Hu
Collaborators:
Affiliated Hospital of Jiangnan University
First Affiliated Hospital of Wenzhou Medical University
Fujian Cancer Hospital
Jiangxi Provincial Cancer Hospital
Zhejiang Cancer Hospital
Treatments:
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

- Patients with newly histologically confirmed non-keratinizing (according to WHO
histologically type)

- Tumor staged as III-IVA (according to the 8th AJCC edition).

- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.

- Age between 18 and 60 years old.

- Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count
≥100000/μL.

- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase
(AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤
2.5×ULN, and bilirubin ≤ 1.5ULN.

- Adequate renal function: creatinine clearance ≥60 ml/min.

- Patients must be informed of the investigational nature of this study and give written
informed consent.

Exclusion Criteria:

- Evidence of distant metastasis

- Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or
nodes.

- Other previous or concomitant cancer.

- Pregnancy or lactation.

- Presence of an uncontrolled concomitant illness including, but not limited to, ongoing
or active infection, immune deficiency, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia or emotional disturbance.