Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

Chaosu Hu

Status and phase

Enrolling

Phase 3

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: gemcitabine and cisplatin (Induction chemotherapy)

Radiation: IMRT

Radiation: IMRT and concurrent cisplatin

Drug: gemcitabine and cisplatin (Induction and adjuvant chemotherapy)

Study type

Interventional

Funder types

Other

Identifiers

NCT03366415

GP2017-02（SANDWICH）

Details and patient eligibility

About

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.

Full 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.

Enrollment

420 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

420 participants in 2 patient groups

Induction chemotherapy+IMRT+adjuvant chemotherapy

Experimental group

Description:

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles.

Treatment: