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Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine/Tiggio
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
  2. No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T and N3M0 stage nasopharyngeal carcinoma).
  3. Aged 18-65;
  4. At least one measurable tumor lesion;
  5. PS (ECOG standard) 0-1;
  6. Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L;
  7. Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value (ULN), total bilirubin < 1.5×ULN;Serum creatinine < 1.5×ULN;
  8. Expected survival period ≥6 months;
  9. Signing informed consent;
  10. Follow up regularly and comply with test requirements.

Exclusion Criteria:

  1. Patients with distant organ metastasis;
  2. Recurrent nasopharyngeal carcinoma;
  3. Creatinine clearance rate <60ml/ min;
  4. Have received chemotherapy, radiotherapy or targeted therapy;
  5. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
  6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
  7. Active systemic infection;
  8. History of serious lung or heart disease;
  9. Drug or alcohol abuse;
  10. No or limited capacity for civil conduct;
  11. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
  12. Receive chronic systemic immunotherapy or hormone therapy outside the study;
  13. Pregnancy or lactation period;
  14. Patients receive blind treatment in other clinical studies.

Sites / Locations

  • Department of radiation oncology, Fujian cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radical chemoradiotherapy plus oral capecitabine/teggiol

Arm Description

Patients with newly diagnosed, non-metastatic stage N3 NPC was given Teggio 40-60mg bid d1-14, q4w, oral maintenance chemotherapy for 1 year or capecitabine 2500mg/m2/d twice daily oral d1-14, q4w after receiving radical chemoradiotherapy.

Outcomes

Primary Outcome Measures

Progression-Free Survival(PFS)
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2020
Last Updated
January 4, 2020
Sponsor
Fujian Cancer Hospital
Collaborators
Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04220528
Brief Title
Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC
Official Title
Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
Collaborators
Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital

4. Oversight

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

5. Study Description

Brief Summary
This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with N3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radical chemoradiotherapy plus oral capecitabine/teggiol
Arm Type
Experimental
Arm Description
Patients with newly diagnosed, non-metastatic stage N3 NPC was given Teggio 40-60mg bid d1-14, q4w, oral maintenance chemotherapy for 1 year or capecitabine 2500mg/m2/d twice daily oral d1-14, q4w after receiving radical chemoradiotherapy.
Intervention Type
Drug
Intervention Name(s)
Capecitabine/Tiggio
Other Intervention Name(s)
Radiation
Intervention Description
Drug: Capecitabine/Tiggio Radical chemoradiotherapy：Induction chemotherapy plus Concurrent chemoradiotherapy Induction chemotherapy：Gemcitabine (1000mg/m2) D1 D8+ nida platinum (80mg/m2) D2 q3w ×3cycle Concurrent chemoradiotherapy：IMRT was used for radiotherapy, during which D1 and D22 were given two cycles of single drug concurrent chemotherapy with nidapatin (100mg/m2).
Primary Outcome Measure Information:
Title
Progression-Free Survival(PFS)
Description
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame
24 months

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: Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T and N3M0 stage nasopharyngeal carcinoma). Aged 18-65; At least one measurable tumor lesion; PS (ECOG standard) 0-1; Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L; Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value (ULN), total bilirubin < 1.5×ULN;Serum creatinine < 1.5×ULN; Expected survival period ≥6 months; Signing informed consent; Follow up regularly and comply with test requirements. Exclusion Criteria: Patients with distant organ metastasis; Recurrent nasopharyngeal carcinoma; Creatinine clearance rate <60ml/ min; Have received chemotherapy, radiotherapy or targeted therapy; Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer); Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc. Active systemic infection; History of serious lung or heart disease; Drug or alcohol abuse; No or limited capacity for civil conduct; The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; Receive chronic systemic immunotherapy or hormone therapy outside the study; Pregnancy or lactation period; Patients receive blind treatment in other clinical studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaojun Lin, DR
Phone
13860603879
Email
linshaojun@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jingfeng Zong, DR
Phone
13365910013
Email
zongjingfeng@126.com
Facility Information:
Facility Name
Department of radiation oncology, Fujian cancer hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaojun Lin, doctor
Phone
0591-62752225
Email
linshaojun@yeah.com

12. IPD Sharing Statement

Learn more about this trial

Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

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