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Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

gemcitabine and cisplatin (Induction and adjuvant chemotherapy)

IMRT

gemcitabine and cisplatin (Induction chemotherapy)

IMRT and concurrent cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, concurrent chemoradiotherapy, sequential chemoradiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction chemotherapy+IMRT+adjuvant chemotherapy

Induction chemotherapy+IMRT and concurrent cisplatin

Arm 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.

Outcomes

Primary Outcome Measures

Failure-free survival

Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Grade III or more mucositis

Grade III or more mucositis during radiotherapy

Secondary Outcome Measures

Overall survival

Overall survival is calculated from randomization to death from any cause.

Locoregional failure-free survival

Locoregional failure-free survival is calculated from randomization to the first locoregional failure.

Distant failure-free survival

Distant failure-free survival is calculated from randomization to the first remote failure.

Short-term treatment response

Treatment response after induction chemotherapy, IMRT and completion of treatment.

Number of participants with adverse events

Incidence of acute and late toxicity

Quality of Life

Use EORTC QLQ-HN35.

Full Information

NCT ID

NCT03366415

First Posted

December 2, 2017

Last Updated

February 16, 2022

Sponsor

Chaosu Hu

Collaborators

Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Affiliated Hospital of Jiangnan University, Fujian Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03366415

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chaosu Hu

Collaborators

Zhejiang Cancer Hospital, Jiangxi Provincial Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Affiliated Hospital of Jiangnan University, Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, concurrent chemoradiotherapy, sequential chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Stratified by stage

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Induction chemotherapy+IMRT+adjuvant chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Induction chemotherapy+IMRT and concurrent cisplatin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

gemcitabine and cisplatin (Induction and adjuvant chemotherapy)

Intervention Description

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT.

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

gemcitabine and cisplatin (Induction chemotherapy)

Intervention Description

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy.

Intervention Type

Radiation

Intervention Name(s)

IMRT and concurrent cisplatin

Intervention Description

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 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week.

Primary Outcome Measure Information:

Title

Failure-free survival

Description

Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Time Frame

3-year

Title

Grade III or more mucositis

Description

Grade III or more mucositis during radiotherapy

Time Frame

From the start of radiotherapy to 30 days after radiotherapy

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival is calculated from randomization to death from any cause.

Time Frame

3-year

Title

Locoregional failure-free survival

Description

Locoregional failure-free survival is calculated from randomization to the first locoregional failure.

Time Frame

3-year

Title

Distant failure-free survival

Description

Distant failure-free survival is calculated from randomization to the first remote failure.

Time Frame

3-year

Title

Short-term treatment response

Description

Treatment response after induction chemotherapy, IMRT and completion of treatment.

Time Frame

Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy.

Title

Number of participants with adverse events

Description

Incidence of acute and late toxicity

Time Frame

up to 3 years

Title

Quality of Life

Description

Use EORTC QLQ-HN35.

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chaosu Hu, MD,PhD

Phone

+86 18017312302

hucsu62@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiayun He, MD

Phone

+86 18017312167

hexiayun1962@163.com

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chaosu Hu, MD,PhD

Phone

+86 18017312302

12. IPD Sharing Statement

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Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC

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