Back to resultsPhase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IMRT and concurrent cisplatin
gemcitabine and cisplatin (Induction chemotherapy)
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Induction Chemotherapy, Concurrent Chemotherapy
Eligibility Criteria
Inclusion Criteria: Age 18-70 years old. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA<4000copies/ml. ECOG Performance status less or equal to 1. Male and no pregnant female. 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: Patients have evidence of relapse or distant metastasis. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Treatment with palliative intent. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 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
- Guangzhou Medical University
- The First Affiliated Hospital of Sun Yat-sen University
- Zhongshan City People's Hospital
- The First Affiliated Hospital of Guangxi Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMRT and concurrent cisplatin
Induction chemotherapy+IMRT and concurrent cisplatin
Arm Description
Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Outcomes
Primary Outcome Measures
Progress-free survival(PFS)
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Secondary Outcome Measures
Overall survival(OS)
defined as the time from random assignment to death from any cause.
Locoregional progression
defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).
Distant progression
defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).
Overall response rate
Tumour response was classified according to RECIST, version 1.1
Incidence of acute and late toxicity
Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979961
Brief Title
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Official Title
Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).
Detailed Description
Patients with low risk NPC( Stage III-IVa, except T4N2/AnyTN3, AJCC 8th and EBV DNA <4000 copies/ml) are randomly assigned to receive CCRT alone or induction chemotherapy plus CCRT. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.12 Gy per fraction with five daily fractions per week to a total dose of 70 Gy. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is progress-free survival. Secondary end points include overall survival (OS), Locoregional progression, Distant progression 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, Induction Chemotherapy, Concurrent Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMRT and concurrent cisplatin
Arm Type
Experimental
Arm Description
Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Arm Title
Induction chemotherapy+IMRT and concurrent cisplatin
Arm Type
Active Comparator
Arm Description
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
Intervention Type
Radiation
Intervention Name(s)
IMRT and concurrent cisplatin
Intervention Description
Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)
Intervention Type
Drug
Intervention Name(s)
gemcitabine and cisplatin (Induction chemotherapy)
Intervention Description
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy
Primary Outcome Measure Information:
Title
Progress-free survival(PFS)
Description
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
defined as the time from random assignment to death from any cause.
Time Frame
2 years
Title
Locoregional progression
Description
defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).
Time Frame
2 years
Title
Distant progression
Description
defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).
Time Frame
2 years
Title
Overall response rate
Description
Tumour response was classified according to RECIST, version 1.1
Time Frame
16 weeks after completion of concurrent chemoradiotherapy
Title
Incidence of acute and late toxicity
Description
Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years old.
Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA<4000copies/ml.
ECOG Performance status less or equal to 1.
Male and no pregnant female.
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:
Patients have evidence of relapse or distant metastasis.
WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Treatment with palliative intent.
History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
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
Hai-Qiang Mai
Phone
862087343643
Email
maihq@sysucc.org.cn
Facility Information:
Facility Name
Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ping Chen, MD
Phone
13302215492
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510062
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Chen, MD
Phone
13826266676
Facility Name
Zhongshan City People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528499
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Lei, MD
Phone
13528227676
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren-Sheng Wang, MD
Phone
13807806008
12. IPD Sharing Statement
Learn more about this trial
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
We'll reach out to this number within 24 hrs