Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine/S-1
Chemotherapy
Head and neck radiotherapy
Local Consolidative Therapy
Sponsored by

About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients with oligometastatic nasopharyngeal carcinoma (newly diagnosed or after treatment) ; patients with first diagnosis of nasopharyngeal carcinoma diagnosed by pathological biopsy; metastatic focus in principle need biopsy pathological diagnosis; but if the patient refuses to take the metastatic biopsy, the clinician decides with clinical evidence
- Patients with a ECOG score of 0,1 or 2 and an expected survival period of more than 6 months; those who can cooperate in observing adverse reactions and outcomes;
- At least one tumor lesion can be measured according to recist 1.1 criteria
- Have good organ function
- Informed consent signed and dated indicating that the patient has been informed of all relevant aspects of the study ;
- Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures ;
- Be willing to comply with arrangements during the study to no longer participate in any other clinical studies related to drugs and medical devices.
Exclusion Criteria:
- Patients with severe history of rapid-onset allergy to any of the drugs used in this study ;
- Patients with local and/or regional recurrence;
- Combine with other malignancies in 5 years (except non-melanin skin cancer or pre-invasion cervical cancer);
- Any of the following conditions existed during the first six months of screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery transplantation, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. patients known to have coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction < 50% and must use an optimized stable medical protocol determined by the therapist, if appropriate, to consult a cardiologist ;
- Active infections, including tuberculosis, hepatitis b, hepatitis c, and human immunodeficiency virus. Patients with hbv surface antigen (hbsag) positive but HBV DNA <1000 copies/ml are eligible to participate in the study ;
- Idiopathic pulmonary fibrosis, drug-induced pneumonia, organic pneumonia (bronchiolitis obliterans),Chest CT scans showing evidence of active pneumonia during history or screening of idiopathic pneumonia;
- Substance abuse or alcohol addiction
- Inability or limitation of civil capacity ;
- Patients with physical or mental disorders who, according to the researchers, can not fully or fully understand the possible complications of the study ;
- May increase the risk associated with the treatment of the study protocol, or may interfere with the interpretation of the study results and (as judged by the researchers) may render the patient unfit to participate in other severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental disorders (including dementia and epilepsy, recent, past year or active suicidal ideation or behavior) or laboratory abnormalities ;
- Patients with expected survival <6 months ;
- Previous diagnosis of immunodeficiency or known Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (aids)-related diseases ;
- Male or female pregnant or lactating women who have fertility but are unwilling or unable to use contraception throughout the study period and at least one year after the treatment programme ;
- Large amounts of glucocorticoids or other immunosuppression have been used within 4 weeks of treatmen
Sites / Locations
- Department of radiation oncology, Fujian cancer hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sufficient Chemotherapy Combine With Maintenance Chemotherapy
Arm Description
Patients with oligometastatic Nasopharyngeal Carcinoma was given S-1 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 sufficient chemotherapy and consolidative local therapy
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
overall survival(OS)
OS was defined as the time from randomization to death from any cause
Full Information
NCT ID
NCT04319471
First Posted
March 22, 2020
Last Updated
March 22, 2020
Sponsor
Fujian Cancer Hospital
Collaborators
Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04319471
Brief Title
Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma
Official Title
Single Arm, Open, Multicenter Phase II Clinical Study of Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 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 sufficient chemoradiotherapy plus oral capecitabine/S-1 for 1 year in the treatment of oligometastatic Nasopharyngeal Carcinoma
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
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sufficient Chemotherapy Combine With Maintenance Chemotherapy
Arm Type
Experimental
Arm Description
Patients with oligometastatic Nasopharyngeal Carcinoma was given S-1 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 sufficient chemotherapy and consolidative local therapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine/S-1
Other Intervention Name(s)
Maintenance chemotherapy
Intervention Description
Drug: Capecitabine/S-1
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Gemcitabine (1000mg/m2) D1 D8+ nidaplatinum (80-100mg/m2) D2 q3w ×4-6cycle
Intervention Type
Radiation
Intervention Name(s)
Head and neck radiotherapy
Intervention Description
IMRT is uesd for the synchronous oligometastatic Nasopharyngeal Carcinoma;
Intervention Type
Other
Intervention Name(s)
Local Consolidative Therapy
Intervention Description
radiotherapy,surgery or interventional therapy for all metastatic sites.
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
12 months and 24 months
Secondary Outcome Measure Information:
Title
overall survival(OS)
Description
OS was defined as the time from randomization to death from any cause
Time Frame
12 months and 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:
Patients with oligometastatic nasopharyngeal carcinoma (newly diagnosed or after treatment) ; patients with first diagnosis of nasopharyngeal carcinoma diagnosed by pathological biopsy; metastatic focus in principle need biopsy pathological diagnosis; but if the patient refuses to take the metastatic biopsy, the clinician decides with clinical evidence
Patients with a ECOG score of 0,1 or 2 and an expected survival period of more than 6 months; those who can cooperate in observing adverse reactions and outcomes;
At least one tumor lesion can be measured according to recist 1.1 criteria
Have good organ function
Informed consent signed and dated indicating that the patient has been informed of all relevant aspects of the study ;
Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures ;
Be willing to comply with arrangements during the study to no longer participate in any other clinical studies related to drugs and medical devices.
Exclusion Criteria:
Patients with severe history of rapid-onset allergy to any of the drugs used in this study ;
Patients with local and/or regional recurrence;
Combine with other malignancies in 5 years (except non-melanin skin cancer or pre-invasion cervical cancer);
Any of the following conditions existed during the first six months of screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery transplantation, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. patients known to have coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction < 50% and must use an optimized stable medical protocol determined by the therapist, if appropriate, to consult a cardiologist ;
Active infections, including tuberculosis, hepatitis b, hepatitis c, and human immunodeficiency virus. Patients with hbv surface antigen (hbsag) positive but HBV DNA <1000 copies/ml are eligible to participate in the study ;
Idiopathic pulmonary fibrosis, drug-induced pneumonia, organic pneumonia (bronchiolitis obliterans),Chest CT scans showing evidence of active pneumonia during history or screening of idiopathic pneumonia;
Substance abuse or alcohol addiction
Inability or limitation of civil capacity ;
Patients with physical or mental disorders who, according to the researchers, can not fully or fully understand the possible complications of the study ;
May increase the risk associated with the treatment of the study protocol, or may interfere with the interpretation of the study results and (as judged by the researchers) may render the patient unfit to participate in other severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental disorders (including dementia and epilepsy, recent, past year or active suicidal ideation or behavior) or laboratory abnormalities ;
Patients with expected survival <6 months ;
Previous diagnosis of immunodeficiency or known Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (aids)-related diseases ;
Male or female pregnant or lactating women who have fertility but are unwilling or unable to use contraception throughout the study period and at least one year after the treatment programme ;
Large amounts of glucocorticoids or other immunosuppression have been used within 4 weeks of treatmen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaojun Lin, DR
Phone
8613860603879
Email
linshaojun@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Qiaojuan Guo, DR
Phone
8615080013157
Email
guoqiaojuan@163.com
Facility Information:
Facility Name
Department of radiation oncology, Fujian cancer hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
12. IPD Sharing Statement
Learn more about this trial
Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma
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