Clinical trial NCT03366415: Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC
Official title: Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
concurrent chemoradiotherapy
sequential chemoradiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: Jiangxi Provincial Cancer Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Affiliated Hospital of Jiangnan University
name: Fujian Cancer Hospital
First posted: 2017-12-08
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified by stage
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent chemoradiotherapy. 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. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is failure-free survival(FFS) and grade III mucositis during radiation. Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility 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 65 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.

Primary outcomes:
measure: Failure-free survival
timeFrame: 3-year
measure: Grade III or more mucositis
timeFrame: From the start of radiotherapy to 30 days after radiotherapy
Secondary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Locoregional failure-free survival
timeFrame: 3-year
measure: Distant failure-free survival
timeFrame: 3-year
measure: Short-term treatment response
timeFrame: Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy.
measure: Number of participants with adverse events
timeFrame: up to 3 years
measure: Quality of Life
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: