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Trial Title:
Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa NPC
NCT ID:
NCT06095167
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
without concurrent cisplatin chemotherapy
Description:
IMRT without concurrent cisplatin chemotherapy
Arm group label:
The immunotherapy and induction chemotherapy plus RT alone group
Intervention type:
Drug
Intervention name:
with concurrent cisplatin chemotherapy
Description:
IMRT with concurrent cisplatin chemotherapy
Arm group label:
The immunotherapy and induction chemotherapy plus CCRT group
Summary:
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin)
plus immunotherapy with concurrent chemoradiotherapy (CCRT) or RT alone in patients with
stage III-IVa nasopharyngeal carcinoma(NPC), in order to confirm the value of
Immunotherapy and concurrent chemotherapy in NPC patients.
Detailed description:
Patients Patients with stage III-Iva(except T3N0M0) non-keratinizing NPC (UICC/AJCC 8th
edition) are randomly assigned to receive immunotherapy and induction chemotherapy plus
CCRT or RT alone. Patients in both groups receive Anti-PD-1 Antibody, gemcitabine (1000
mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. The
immunotherapy and induction chemotherapy plus CCRT group receive cisplatin 80-100 mg/m²
every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT).
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. Our primary endpoint is
failure-free survival(FFS). 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing (according to WHO
histologically type).
- Tumor staged as III-Iva(except T3N0M0) (according to the 8th AJCC 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 or < 18.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer,
in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
emphasize effective contraception during the treatment period).
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of radiation oncology, Fujian cancer hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Start date:
January 1, 2024
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095167
