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Recruiting NCT05979961

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

Phase III Interventional Nasopharyngeal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMRT and concurrent cisplatin, gemcitabine and cisplatin (Induction chemotherapy).
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Progress-free survival(PFS) [Time frame: 3 years]
Secondary outcome measures (5)
  • Overall survival(OS) [Time frame: 3 years]
  • Locoregional progression [Time frame: 3 years]
  • Distant progression [Time frame: 3 years]
  • Overall response rate [Time frame: 16 weeks after completion of concurrent chemoradiotherapy]
  • Incidence of acute and late toxicity [Time frame: 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 8 centers
  • Guangzhou Panyu Central Hospital — Guangzhou
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Zhongshan City People's Hospital — Zhongshan
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • Cancer Hospital of Guizhou Province — Guiyang
  • Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology — Wuhan
  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology; — Wuhan
  • Hunan Cancer Hospital — Changsha

Identifiers

NCT: NCT05979961 · 2022-FXY-298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗