Brief Title
Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title
Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
Brief Summary
The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy
alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with
locoregionally advanced nasopharyngeal carcinoma (LA-NPC).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Disease-free survival
Secondary Outcome
Overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil
Study Arms / Comparison Groups
IC plus RT
Description: Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
562
Start Date
June 1, 2020
Completion Date
May 30, 2025
Primary Completion Date
May 30, 2022
Eligibility Criteria
Inclusion Criteria:
- Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma
(differentiated or undifferentiated, ie WHO type II or III).
- Age ≥ 18 and ≤ 65 years old.
- Tumor staged as III/IVa (according to the 8th AJCC edition).
- No evidence of distant metastasis (M0).
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
- Adequate marrow: White blood cells (WBC) ≥ 4 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L,
platelets (PLT) ≥ 100 × 10^9/L (or within the normal range of the laboratory)
- 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.
- Written informed consent.
Exclusion Criteria:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age > 65 or < 18.
- Treatment with palliative intent.
- Previous history of malignant tumors, well-treated basal cell carcinoma or squamous
cell carcinoma and cervical carcinoma in situ outer.
- Pregnancy or lactation.
- History of previous RT (except for non-melanomatous skin cancers outside intended RT
treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or
nodes.
- Any other serious diseases, which may bring greater risk or affect the compliance of
the test, 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
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xingchen Peng, MD, PhD, +86 18980606753, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04414566
Organization ID
2020HXFH037
Responsible Party
Principal Investigator
Study Sponsor
West China Hospital
Study Sponsor
Xingchen Peng, MD, PhD, Principal Investigator, West China Hospital
Verification Date
May 2020