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

Primary Purpose

Locally Advanced Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
IMRT/TOMO
Chemotherapy
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Nasopharyngeal Carcinoma focused on measuring nasopharyngeal carcinoma, Induction chemotherapy, radiotherapy, chemoradiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xiaozhong ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IC+RT group

IC+CCRT group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progress Free Survival (PFS)
PFS means assignment to the date of any local or distant progress of the disease.

Secondary Outcome Measures

Overall Survival (OS)
The overall survival denote to assignment to date of death from any cause.
Adverse Events
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.

Full Information

First Posted
December 24, 2016
Last Updated
January 9, 2017
Sponsor
Zhejiang Cancer Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT03015727
Brief Title
Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
Acronym
IRCNPC
Official Title
Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Recruiting
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Nasopharyngeal Carcinoma
Keywords
nasopharyngeal carcinoma, Induction chemotherapy, radiotherapy, chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IC+RT group
Arm Type
Experimental
Arm Description
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.
Arm Title
IC+CCRT group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
DOC
Intervention Description
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
Intervention Type
Radiation
Intervention Name(s)
IMRT/TOMO
Intervention Description
intensity modulated radiation therapy or tomotherapy
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
concurrent chemotherapy
Intervention Description
2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
Primary Outcome Measure Information:
Title
Progress Free Survival (PFS)
Description
PFS means assignment to the date of any local or distant progress of the disease.
Time Frame
3 years after the inception assignment
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The overall survival denote to assignment to date of death from any cause.
Time Frame
3 years and 5 years after the inception of the assignment
Title
Adverse Events
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system) No evidence of distant metastasis (M0) Performance status: KPS>70 With normal liver function test (ALT, AST <1.5ULN) Renal: creatinine clearance >60ml/min Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L. With controlled blood glucose for diabetes patients Written informed consent satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age >65 or <18 With a history of renal disease Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Peripheral neuropathy Emotional disturbance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Chen
Email
cxzfyun@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xiaozhong Chen
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Phone
+86-571-88128202
Email
cxzfyun@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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