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Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma (IRCNPC)

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ClinicalTrials.gov Identifier: NCT03015727
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborators:
Zhejiang Provincial People's Hospital
The Central Hospital of Lishui City
Jinhua Central Hospital
First Affiliated Hospital of Wenzhou Medical University
Ningbo Medical Center Lihuili Eastern Hospital
People's Hospital of Quzhou
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE December 24, 2016
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date January 10, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
Progress Free Survival (PFS) [ Time Frame: 3 years after the inception assignment ]
PFS means assignment to the date of any local or distant progress of the disease.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
  • Overall Survival (OS) [ Time Frame: 3 years and 5 years after the inception of the assignment ]
    The overall survival denote to assignment to date of death from any cause.
  • Adverse Events [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years ]
    Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
Official Title  ICMJE Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Brief Summary In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
Detailed Description In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Docetaxel
    3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
    Other Name: DOC
  • Drug: Cisplatin
    3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
    Other Name: DDP
  • Radiation: IMRT/TOMO
    intensity modulated radiation therapy or tomotherapy
  • Drug: Chemotherapy
    2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
    Other Name: concurrent chemotherapy
Study Arms  ICMJE
  • Experimental: IC+RT group
    3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
    Interventions:
    • Drug: Docetaxel
    • Drug: Cisplatin
    • Radiation: IMRT/TOMO
  • Active Comparator: IC+CCRT group
    3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
    Interventions:
    • Drug: Docetaxel
    • Drug: Cisplatin
    • Radiation: IMRT/TOMO
    • Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2017)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing carcinoma.
  2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
  3. No evidence of distant metastasis (M0)
  4. Performance status: KPS>70
  5. With normal liver function test (ALT, AST <1.5ULN)
  6. Renal: creatinine clearance >60ml/min
  7. Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
  8. With controlled blood glucose for diabetes patients
  9. Written informed consent
  10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

  1. WHO type I squamous cell carcinoma or adenocarcinoma
  2. Age >65 or <18
  3. With a history of renal disease
  4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
  5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
  6. Patient is pregnant or lactating
  7. Peripheral neuropathy
  8. Emotional disturbance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaozhong Chen cxzfyun@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015727
Other Study ID Numbers  ICMJE ZhejiangCH 01536224
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE
  • Zhejiang Provincial People's Hospital
  • The Central Hospital of Lishui City
  • Jinhua Central Hospital
  • First Affiliated Hospital of Wenzhou Medical University
  • Ningbo Medical Center Lihuili Eastern Hospital
  • People's Hospital of Quzhou
Investigators  ICMJE
Study Chair: Xiaozhong Chen Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP