Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979961
• Other study ID #: 2022-FXY-298
• Status: Recruiting
• Phase: Phase 3
• Start date: September 7, 2023
• Est. completion date: September 2027

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: Hai-Qiang Mai
• Phone: 862087343643
• Email: maihq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 18-70 years old.

2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).

3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA<4000copies/ml.

4. ECOG Performance status less or equal to 1.

5. Male and no pregnant female.

6. Adequate marrow: leucocyte count = 4000/µL, hemoglobin = 90g/L and platelet count = 100000/µL.

7. 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.

8. Adequate renal function: creatinine clearance = 60 ml/min.

9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. Patients have evidence of relapse or distant metastasis.

2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

3. Treatment with palliative intent.

4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).

5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).

7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

8. 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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• IMRT and concurrent cisplatin
Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)

Drug:
• gemcitabine and cisplatin (Induction chemotherapy)
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Guangzhou Medical University	Guangzhou	Guangdong
China	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Cancer Hospital of Guizhou Province	Guiyang	Guizhou
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;	Wuhan	Hubei
China	Zhongshan City People's Hospital	Zhongshan	Guangdong

Sponsors (10)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Hospital of Guizhou Province, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou Medical University, Guangzhou Panyu Central Hospital, Hunan Cancer Hospital, Tongji Hospital, Wuhan Union Hospital, China, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	Overall survival(OS)	defined as the time from random assignment to death from any cause.	2 years
Secondary	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).	2 years
Secondary	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).	2 years
Secondary	Overall response rate	Tumour response was classified according to RECIST, version 1.1	16 weeks after completion of concurrent chemoradiotherapy
Secondary	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.	2 years