Sufficient Chemotherapy Combine With Maintenance Chemotherapy in the Treatment of Oligometastatic Nasopharyngeal Carcinoma

NCT ID: NCT04319471

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-06-01

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

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sufficient Chemotherapy Combine With Maintenance Chemotherapy

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

Group Type: EXPERIMENTAL

Capecitabine/S-1

Intervention Type: DRUG

Drug: Capecitabine/S-1

Chemotherapy

Intervention Type: DRUG

Gemcitabine (1000mg/m2) D1 D8+ nidaplatinum (80-100mg/m2) D2 q3w ×4-6cycle

Head and neck radiotherapy

Intervention Type: RADIATION

IMRT is uesd for the synchronous oligometastatic Nasopharyngeal Carcinoma；

Local Consolidative Therapy

Intervention Type: OTHER

radiotherapy，surgery or interventional therapy for all metastatic sites.

Interventions

Capecitabine/S-1

Drug: Capecitabine/S-1

Intervention Type: DRUG

Chemotherapy

Gemcitabine (1000mg/m2) D1 D8+ nidaplatinum (80-100mg/m2) D2 q3w ×4-6cycle

Intervention Type: DRUG

Head and neck radiotherapy

IMRT is uesd for the synchronous oligometastatic Nasopharyngeal Carcinoma；

Intervention Type: RADIATION

Local Consolidative Therapy

radiotherapy，surgery or interventional therapy for all metastatic sites.

Intervention Type: OTHER

Other Intervention Names

Maintenance chemotherapy

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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;

3. At least one tumor lesion can be measured according to recist 1.1 criteria

4. Have good organ function

5. Informed consent signed and dated indicating that the patient has been informed of all relevant aspects of the study ;

6. Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures ;

7. 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

1. Patients with severe history of rapid-onset allergy to any of the drugs used in this study ;

2. Patients with local and/or regional recurrence;

3. Combine with other malignancies in 5 years (except non-melanin skin cancer or pre-invasion cervical cancer);

4. 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 ;

5. 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 ;

6. 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;

7. Substance abuse or alcohol addiction

8. Inability or limitation of civil capacity ;

9. Patients with physical or mental disorders who, according to the researchers, can not fully or fully understand the possible complications of the study ;

10. 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 ;

11. Patients with expected survival <6 months ;

12. Previous diagnosis of immunodeficiency or known Human Immunodeficiency Virus (HIV) or acquired immunodeficiency syndrome (aids)-related diseases ;

13. 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 ;

14. Large amounts of glucocorticoids or other immunosuppression have been used within 4 weeks of treatmen

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, China

Countries

China

Central Contacts

Shaojun Lin, DR

Role: CONTACT

linshaojun@yeah.net

8613860603879

Qiaojuan Guo, DR

Role: CONTACT

guoqiaojuan@163.com

8615080013157

Other Identifiers

NPC003.1

Identifier Type: -

Identifier Source: org_study_id