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Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03919552
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:
The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.

Condition or disease Intervention/treatment Phase
Cisplatin Carboplatin NPC Drug: Docetaxel,Carboplatin Drug: Docetaxel,Cisplatin Radiation: Carboplatin-based concurrent chemoradiotherapy Radiation: Cisplatin-based concurrent chemoradiotherapy Phase 3

Detailed Description:
Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy.
Drug: Docetaxel,Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
Other Name: TC induction chemotherapy

Radiation: Carboplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent carboplatin

Active Comparator: Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy.
Drug: Docetaxel,Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
Other Name: TP induction chemotherapy

Radiation: Cisplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin




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


Secondary Outcome Measures :
  1. Locoregional failure-free survival [ Time Frame: 3-year ]
    Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.

  2. Distant failure-free survival [ Time Frame: 3-year ]
    Distant failure-free survival is calculated from randomisation to the first locoregional failure.

  3. The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy. ]
    The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.

  4. Toxic effects [ Time Frame: 3-year ]
    Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.

  5. Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  • Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer 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 years or <18 years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (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.

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): NCT03919552


Contacts
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Contact: Jian Guan, Ph.D. +86-13632102247 51643930@qq.com

Locations
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China, Guangdong
Southern medical university Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jian Guan, M.D.    86+13632102247    guanjian5461@163.com   
Principal Investigator: Jian Guan, M.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Study Chair: Jian Guan Nanfang Hospital of Southern Medical University

Publications:

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03919552     History of Changes
Other Study ID Numbers: LC2016PY015
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nanfang Hospital of Southern Medical University:
Nasopharyngeal Carcinoma
cisplatin
carboplatin

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
Cisplatin
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action