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

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ClinicalTrials.gov Identifier: NCT04414566
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Xingchen Peng, West China Hospital

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).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil Radiation: IMRT Radiation: IMRT and concurrent cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: GP;TPF

Radiation: 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.

Active Comparator: 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.
Drug: 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.
Other Name: GP;TPF

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.




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3-year ]
    Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.

  2. Locoregional recurrence-free survival [ Time Frame: 3-year ]
    Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence.

  3. Distant metastasis-free survival [ Time Frame: 3-year ]
    Distant metastasis-free survival is calculated from randomization to the first remote metastases.

  4. Objective response rates after treatments [ Time Frame: At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy ]
  5. Number of participants with adverse events [ Time Frame: Every week during treatment, up to 4 weeks after treatment. ]
    Incidence of acute toxicity



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414566


Contacts
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Contact: Xingchen Peng, MD, PhD +86 18980606753 pxx2014@scu.edu.cn

Locations
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China, Sichuan
Xingchen Peng
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Xingchen Peng, MD, PhD West China Hospital
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Responsible Party: Xingchen Peng, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT04414566    
Other Study ID Numbers: 2020HXFH037
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xingchen Peng, West China Hospital:
Nasopharyngeal Carcinoma
Induction Chemotherapy
Concurrent Chemoradiotherapy
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Docetaxel
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents