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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03919552

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

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:Cisplatin
    Carboplatin
    NPC
  • Intervention/Treatment: Drug: Docetaxel,Carboplatin
    Drug: Docetaxel,Cisplatin
    Radiation: Carboplatin-based concurrent chemoradiotherapy
    Radiation: Cisplatin-based concurrent chemoradiotherapy
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • 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 2018
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: June 2023
Arms and interventions
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.

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

Radiation: Cisplatin-based concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Outcome Measures
  • 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. Toxic effects [ Time Frame: 3-year ]
    Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.
  • 2. Overall survival [ Time Frame: 3-year ]
    Overall survival is calculated from randomization to death from any cause.
  • 3. Locoregional failure-free survival [ Time Frame: 3-year ]
    Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.
  • 4. Distant failure-free survival [ Time Frame: 3-year ]
    Distant failure-free survival is calculated from randomisation to the first locoregional failure.
  • 5. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 64 Years (Adult, Older 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 1.5×ULN), and emotional disturbance.

Contacts and Locations
Contacts

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

Locations

China, Guangdong
Southern medical university
Guangzhou

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

Study Chair: Jian Guan Nanfang Hospital of Southern Medical University

More Information