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Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Cisplatin, Carboplatin, NPC

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Docetaxel,Carboplatin

Docetaxel,Cisplatin

Carboplatin-based concurrent chemoradiotherapy

Cisplatin-based concurrent chemoradiotherapy

About this trial

This is an interventional treatment trial for Cisplatin focused on measuring Nasopharyngeal Carcinoma, cisplatin, carboplatin

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/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 ≤ULN.
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:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥65 years or <18 years.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation.
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, 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

Southern medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carboplatin

Cisplatin

Arm Description

Patients receive carboplatin (AUC 4 on day 1) every three weeks

Patients receive cisplatin (75mg/m2 on day 1) every three weeks

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.

Secondary Outcome Measures

Locoregional failure-free survival

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

Distant failure-free survival

Distant failure-free survival is calculated from randomisation to the first locoregional failure.

The initial response rates after treatments

The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.

Toxic effects

Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.

Overall survival

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

Full Information

NCT ID

NCT03919552

First Posted

April 25, 2018

Last Updated

June 14, 2023

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03919552

Brief Title

Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：: A Phase 3 Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 31, 2018 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.

Detailed Description

Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; 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

Cisplatin, Carboplatin, NPC

Keywords

Nasopharyngeal Carcinoma, cisplatin, carboplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

482 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carboplatin

Arm Type

Experimental

Arm Description

Patients receive carboplatin (AUC 4 on day 1) every three weeks

Arm Title

Cisplatin

Arm Type

Active Comparator

Arm Description

Patients receive cisplatin (75mg/m2 on day 1) every three weeks

Intervention Type

Drug

Intervention Name(s)

Docetaxel,Carboplatin

Other Intervention Name(s)

TC induction chemotherapy

Intervention Description

Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Docetaxel,Cisplatin

Other Intervention Name(s)

TP induction chemotherapy

Intervention Description

Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

Carboplatin-based concurrent chemoradiotherapy

Other Intervention Name(s)

Radical radiotherapy and concurrent carboplatin

Intervention Description

Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

Cisplatin-based concurrent chemoradiotherapy

Other Intervention Name(s)

Radical radiotherapy and concurrent cisplatin

Intervention Description

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

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

Secondary Outcome Measure Information:

Title

Locoregional failure-free survival

Description

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

Time Frame

3-year

Title

Distant failure-free survival

Description

Distant failure-free survival is calculated from randomisation to the first locoregional failure.

Time Frame

3-year

Title

The initial response rates after treatments

Description

The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.

Time Frame

A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.

Title

Toxic effects

Description

Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.

Time Frame

3-year

Title

Overall survival

Description

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

Time Frame

3-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition). No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count ≥4000/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 ≤ULN. 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: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Age ≥65 years or <18 years. Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, 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

Jian Guan, Ph.D.

Phone

+86-13632102247

51643930@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Guan

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Southern medical university

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Guan, M.D.

Phone

86+13632102247

guanjian5461@163.com

First Name & Middle Initial & Last Name & Degree

Jian Guan, M.D.

12. IPD Sharing Statement

Plan to Share IPD

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Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

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