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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Locally Advanced Nasopharyngeal Carcinoma Drug: Docetaxel Drug: Cisplatin Radiation: IMRT/TOMO Drug: Chemotherapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Study Start Date : December 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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:

  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
Contacts and Locations
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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): NCT03015727


Contacts
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Contact: Xiaozhong Chen cxzfyun@sina.com

Locations
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China, Zhejiang
Xiaozhong Chen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    +86-571-88128202    cxzfyun@sina.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
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
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Study Chair: Xiaozhong Chen Zhejiang Cancer Hospital
More Information
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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03015727    
Other Study ID Numbers: ZhejiangCH 01536224
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhejiang Cancer Hospital:
nasopharyngeal carcinoma
Induction chemotherapy
radiotherapy
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
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action