Brief Title
Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
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
Brief 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.
Detailed 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free Survival
Secondary Outcome
Overall Survival
Condition
Nasopharyngeal Carcinoma
Intervention
Docetaxel,Cisplatin,Fluorouracil
Study Arms / Comparison Groups
Induction CT+IMRT alone
Description: Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
440
Start Date
March 2015
Completion Date
December 2021
Primary Completion Date
May 2021
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Wei Jiang, Ph.D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02434614
Organization ID
GLMU-01
Responsible Party
Sponsor-Investigator
Study Sponsor
Wei Jiang
Collaborators
Wuzhou Red Cross Hospital
Study Sponsor
Wei Jiang, Ph.D., Study Director, Guilin Medical University Affiliated Hospital
Verification Date
May 2018