Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT04414566

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 562 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2025-05-30

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).

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IC plus RT

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.

Group Type: EXPERIMENTAL

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil

Intervention Type: DRUG

Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

IMRT

Intervention Type: RADIATION

Intensity modulated-radiotherapy (IMRT) is given as 2.0 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.

IC plus CCRT

Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.

Group Type: ACTIVE_COMPARATOR

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil

Intervention Type: DRUG

Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

IMRT and concurrent cisplatin

Intervention Type: RADIATION

Intensity modulated-radiotherapy (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, concurrently with cisplatin 100 mg/m\^2 every 3 weeks for 3 cycles.

Interventions

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil

Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

Intervention Type: DRUG

IMRT

Intensity modulated-radiotherapy (IMRT) is given as 2.0 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.

Intervention Type: RADIATION

IMRT and concurrent cisplatin

Intensity modulated-radiotherapy (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, concurrently with cisplatin 100 mg/m\^2 every 3 weeks for 3 cycles.

Intervention Type: RADIATION

Other Intervention Names

GP;TPF

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xingchen Peng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingchen Peng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Xingchen Peng

Chengdu, Sichuan, China

Countries

China

Central Contacts

Xingchen Peng, MD, PhD

Role: CONTACT

pxx2014@scu.edu.cn

+86 18980606753

Other Identifiers

2020HXFH037

Identifier Type: -

Identifier Source: org_study_id