Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Randomized Phase III Non-inferiority Study of Induction Chemotherapy Followed by IMRT Alone Versus Induction Chemotherapy Followed by IMRT Plus Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02434614
• Other study ID #: GLMU-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: December 2021

Study information

• Verified date: May 2018
• Source: Guilin Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally advanced NPC. However, most of these evidences of standard treatment for locoregionally advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve survival rates for patients with locoregionally advanced disease, but increased the severity of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose this randomized phase III non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in locoregionally advanced NPC during IMRT era.

Description:

Patients with with previously untreated non-metastatic newly histologically-confirmed non-keratinizing III-IVb NPC (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy followed by IMRT alone (investigational group) or induction chemotherapy followed by IMRT plus concurrent chemotherapy (control group). During induction chemotherapy, patients in both groups receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks. During radiotherapy, patients in investigational group received IMRT alone and patients in control group received IMRT, concurrently with weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. The primary endpoint is failure-free survival(FFS). Secondary clinical endpoints include overall survival (OS), locoregional failure-free survival (LRFFS), distant failure-free survival (DFFS) rates and toxic effects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: December 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type); Tumor staged as III-IVb (according to the 7th AJCC edition); No pregnant female; Age between 18-70; Normal complete blood count level (hemoglobin >10 g/dL, white blood cells =4000/µL, platelets =100 000/µL); Normal hepatic functions (serum total bilirubin =1.6 mg/dL, serum transminase < 2.5 times higher than upper limit); Normal renal function (serum creatinine =1.5 mg/dL, creatinine clearance =60 mL/min); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Without radiotherapy or chemotherapy; Patients must give signed informed consent.

Exclusion Criteria:

Disease progression in the process of the treatment; The presence of uncontrolled life-threatening illness; History of previous radiotherapy or chemotherapy; Pregnancy or lactation.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Docetaxel,Cisplatin,Fluorouracil
Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks.

Radiation:
• Intensity-modulated radiation therapy (IMRT)
IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.

Drug:
• Cisplatin
Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.

Locations

Country	Name	City	State
China	Affiliated Hospital of Youjiang Medical University for Nationalities	Baise	Guangxi
China	Guigang People's Hospital	Guigang	Guangxi
China	Guangxi Naxishan Hospital	Guilin	Guangxi
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Nanning Monority Hospital	Nanning	Guangxi
China	Wuzhou Red Cross Hospital	Wuzhou	Guangxi

Sponsors (7)

Lead Sponsor	Collaborator
Wei Jiang	Affiliated Hospital of Youjiang Medical University for Nationalities, Guangxi Naxishan Hospital, Guigang People's Hospital, Liuzhou People's Hospital, Nanning Monority Hospital, Wuzhou Red Cross Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Progression-free survival is to first disease progression [local recurrence and/or distant metastasis] or death from any cause.	3 years
Secondary	Overall Survival	Overall survival is from randomization to death of any cause or last follow-up.	3 years
Secondary	Locoregional Failure-free Survival	Locoregional failure-free survival is from randomization to locoregional progression.	3 years
Secondary	Distant Failure-free Survival	Distant failure-free survival is from randomization to first distant metastasis.	3 years
Secondary	Number of Participants with Adverse Events	Incidence of acute and late toxicity	3 years