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Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Not yet recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil

IMRT

IMRT and concurrent cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Induction Chemotherapy, Concurrent Chemoradiotherapy

Eligibility Criteria

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

Inclusion Criteria:

Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
Age ≥ 18 and ≤ 65 years old.
Tumor staged as III/IVa (according to the 8th AJCC edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
Adequate marrow: White blood cells (WBC) ≥ 4 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L, platelets (PLT) ≥ 100 × 10^9/L (or within the normal range of the laboratory)
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 ≤ ULN.
Adequate renal function: creatinine clearance ≥ 60 ml/min.
Written informed consent.

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age > 65 or < 18.
Treatment with palliative intent.
Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
Pregnancy or lactation.
History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Any other serious diseases, which may bring greater risk or affect the compliance of the test, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Sites / Locations

Xingchen Peng

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IC plus RT

IC plus CCRT

Arm Description

Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy.

Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.

Outcomes

Primary Outcome Measures

Disease-free survival

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

Secondary Outcome Measures

Overall survival

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

Locoregional recurrence-free survival

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

Distant metastasis-free survival

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

Objective response rates after treatments

Number of participants with adverse events

Incidence of acute toxicity

Full Information

NCT ID

NCT04414566

First Posted

May 24, 2020

Last Updated

May 31, 2020

Sponsor

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04414566

Brief Title

Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2020 (Anticipated)

Primary Completion Date

May 30, 2022 (Anticipated)

Study Completion Date

May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, Induction Chemotherapy, Concurrent Chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

562 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IC plus RT

Arm Type

Experimental

Arm Description

Arm Title

IC plus CCRT

Arm Type

Active Comparator

Arm Description

Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.

Intervention Type

Drug

Intervention Name(s)

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil

Other Intervention Name(s)

GP;TPF

Intervention Description

Patients receive GP gemcitabine (1000 mg/m^2 d1,8) and cisplatin (80mg/m^2 d1) or TPF docetaxel (60mg/m^2 on day 1), cisplatin (60mg/m^2 on day 1) and fluorouracil (600mg/m^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Intervention Type

Radiation

Intervention Name(s)

IMRT and concurrent cisplatin

Intervention Description

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m^2 every 3 weeks for 3 cycles.

Primary Outcome Measure Information:

Title

Disease-free survival

Description

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

Time Frame

3-year

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 recurrence-free survival

Description

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

Time Frame

3-year

Title

Distant metastasis-free survival

Description

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

Time Frame

3-year

Title

Objective response rates after treatments

Time Frame

At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy

Title

Number of participants with adverse events

Description

Incidence of acute toxicity

Time Frame

Every week during treatment, up to 4 weeks after treatment.

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: Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III). Age ≥ 18 and ≤ 65 years old. Tumor staged as III/IVa (according to the 8th AJCC edition). No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. Adequate marrow: White blood cells (WBC) ≥ 4 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L, platelets (PLT) ≥ 100 × 10^9/L (or within the normal range of the laboratory) 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 ≤ ULN. Adequate renal function: creatinine clearance ≥ 60 ml/min. Written informed consent. Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Age > 65 or < 18. Treatment with palliative intent. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer. Pregnancy or lactation. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any other serious diseases, which may bring greater risk or affect the compliance of the test, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Central Contact Person:

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

Xingchen Peng, MD, PhD

Phone

+86 18980606753

pxx2014@scu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xingchen Peng, MD, PhD

Organizational Affiliation

West China Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xingchen Peng

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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