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A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

Primary Purpose

Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy
3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
  2. According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
  3. Patients who have not received disease-related anti-tumor system therapy;
  4. Age 18~70 years;
  5. Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
  6. Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
  7. Cartesian score ≥70; or ECOG PS 0 or 1
  8. Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
  9. Sign the informed consent.

Exclusion Criteria:

  1. Patients with distant metastases were identified at the time of diagnosis;
  2. Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
  3. Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
  4. Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
  5. A woman who is pregnant or lactating;
  6. Known active HIV or HBV, HCV infection;
  7. Known to be allergic to drugs that may be used;
  8. The researchers did not consider participants to be eligible for this study.

Sites / Locations

  • Fujian Medical University Union Hospital
  • Cancer prevention and treatment center, sun yat-sen university
  • The first affiliated hospital, college of medicinle, Zhejiang University
  • Zhejiang Cancer Hospital
  • Zhejiang Provincial People's Hospital
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
  • Zhejiang Xiaoshan Hospital
  • Jinhua Central Hospital
  • Lishui City Central Hospital
  • Ningbo Yinzhou People's Hospital
  • Ningbo No.2 Hospital
  • People's Hospital of Quzhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy

3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy

Arm Description

Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy

3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy

Outcomes

Primary Outcome Measures

5-year overall survival
the duration between the date of diagnosed and date of patient death
5-year metastatic free survival
the duration between the date of diagnosed and date of metastasis

Secondary Outcome Measures

5-year disease-free survival
the duration between the date of diagnosed and date of related disease
5-year recurrence-free survival
the duration between the date of diagnosed and date of recurrence
Safety (incidence of grade 3/4 adverse reactions)
treatment related toxic effects

Full Information

First Posted
August 13, 2019
Last Updated
May 10, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04061278
Brief Title
A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients
Official Title
A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy
Keywords
Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy
Arm Type
Experimental
Arm Description
Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy
Arm Title
3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy
Arm Type
Active Comparator
Arm Description
3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy
Intervention Description
4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy
Intervention Description
3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy
Primary Outcome Measure Information:
Title
5-year overall survival
Description
the duration between the date of diagnosed and date of patient death
Time Frame
5 years
Title
5-year metastatic free survival
Description
the duration between the date of diagnosed and date of metastasis
Time Frame
5 years
Secondary Outcome Measure Information:
Title
5-year disease-free survival
Description
the duration between the date of diagnosed and date of related disease
Time Frame
5 years
Title
5-year recurrence-free survival
Description
the duration between the date of diagnosed and date of recurrence
Time Frame
5 years
Title
Safety (incidence of grade 3/4 adverse reactions)
Description
treatment related toxic effects
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology; According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma); Patients who have not received disease-related anti-tumor system therapy; Age 18~70 years; Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min; Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL; Cartesian score ≥70; or ECOG PS 0 or 1 Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone. Sign the informed consent. Exclusion Criteria: Patients with distant metastases were identified at the time of diagnosis; Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis; Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site; Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment; A woman who is pregnant or lactating; Known active HIV or HBV, HCV infection; Known to be allergic to drugs that may be used; The researchers did not consider participants to be eligible for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qichun Wei
Phone
0571-87783522
Email
qichun_wei@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Xu
Phone
0571-87783522
Email
shanyefengxu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qichun Wei
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benhua Xu
Facility Name
Cancer prevention and treatment center, sun yat-sen university
City
Guandong
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanhong Gao
Facility Name
The first affiliated hospital, college of medicinle, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senxiang Yan
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongshi Jia
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zexin Chen
Phone
+86 0571 87783759
Email
keyanlunli_zheer@163.com
Facility Name
Zhejiang Xiaoshan Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
311200
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoping Han
Facility Name
Jinhua Central Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wangyuan Hu
Facility Name
Lishui City Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dexi Du
Facility Name
Ningbo Yinzhou People's Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chen
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuangzhou Rao
Facility Name
People's Hospital of Quzhou
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huijuan He

12. IPD Sharing Statement

Learn more about this trial

A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

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