GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT03723343

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2021-06-30

Brief Summary

Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc.

Detailed Description

1. The main purpose: Whether the GP program can improve the efficiency of patients with nasopharyngeal carcinoma, especially overall survival (OS), in the TPF program. 2. Secondary purpose: To compare the progression-free survival (PFS) local failure-free survival (LR-FFS), the short-term remission rate of the tumor, the adverse chemotherapy response, and the treatment compliance Sex, as well as quality of life. 3. Significance of the research project Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Platinum-based chemotherapy is used in the treatment of distant metastasis and metastasis. It can effectively alleviate local symptoms and reduce local symptoms. The tumor volume thereby reduces the high dose area of the target area. Primary lesions and lymphatic drainage area radiotherapy can reduce tumor burden, relieve symptoms, and improve quality of life.

Conditions

Advanced Nasopharyngeal Carcinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental: GP+IMRT

Test group: GP-induced chemotherapy (Gemcitabine 1000 mg/m2 d1, 8+Cisplatin 80 mg/m2 d1, once every 3 weeks, 4/6 course) + IMRT radiotherapy alone

GP+IMRT

Intervention Type: DRUG

Gemcitabine 1000 mg/m2 intravenously, d1\&d8 +Cisplatin 80 mg/m2 intravenously, d1 21\~28 days/cycle, 4 patients with oligometastasis, 6 cycles with multiple metastases

Active Comparator: TPF+IMRT

Control group: TPF-induced chemotherapy (Docetaxel: 75 mg/m2d1, Cisplatin 75 mg/m2, d1\~d5, 5-fluorouracil 750 mg/m2/dd1\~d5, 4/6 course) + IMRT radiotherapy alone

TPF+IMRT

Intervention Type: DRUG

Docetaxel: 75mg/m2 intravenous drip, d1+Cisplatin75mg/m2 intravenous drip, d1\~d5+5-fluorouracil 750mg/m2/d intravenous drip, d1\~d521\~28 days/cycle, patients with oligometastasis take 4 cycles, moreTransfer patients for 6 cycles

Interventions

GP+IMRT

Gemcitabine 1000 mg/m2 intravenously, d1\&d8 +Cisplatin 80 mg/m2 intravenously, d1 21\~28 days/cycle, 4 patients with oligometastasis, 6 cycles with multiple metastases

Intervention Type: DRUG

TPF+IMRT

Docetaxel: 75mg/m2 intravenous drip, d1+Cisplatin75mg/m2 intravenous drip, d1\~d5+5-fluorouracil 750mg/m2/d intravenous drip, d1\~d521\~28 days/cycle, patients with oligometastasis take 4 cycles, moreTransfer patients for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Experimental group; Control group

Eligibility Criteria

Inclusion Criteria

1. The pathological type is non-keratinized cancer (according to the pathological classification of the World Health Organization, WHO).

2. The stage is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I).

3. There is evidence of distant transfer (M1).

4. functional status: Karnofsky scale (KPS) > 70 (Appendix II).

5. normal bone marrow function: white blood cell count > 4 × 109 / L, hemoglobin > 90g / L and platelet count > 100 × 109 / L.

6. normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (alkaline phosphatase, ALP) < 2.5 x ULN and bilirubin < ULN.

7. normal renal function: creatinine clearance (creatinine clearance) > 60 ml / min.

8. The patient must be informed of the basic content of the study and sign an informed consent form.

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Exclusion Criteria

1. the pathological type is WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma.

2. age > 65 years old or < 18 years old.

3. a history of malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.

4. Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).

5. has received radiation therapy (if it is non-melanoma skin cancer and the previous lesion is placed

Except for the target area of treatment.

6. primary lesions and cervical metastases have received chemotherapy or surgery (except for diagnostic treatment).

7. accompanied by other serious diseases, may bring greater risk or affect the compliance of the test. For example: unstable heart disease, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose > 1.5 x ULN), and mental illness. -

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

Sponsors

Guiyang Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Jing

Head and neck cancer director, chief researcher, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinhua Long, Master

Role: PRINCIPAL_INVESTIGATOR

Guizhou Provincial Cancer Hospital

Locations

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Countries

China

Central Contacts

Feng Jin, Bachelor

Role: CONTACT

jinf8865@yeah.net

0851-86512802

Jinhua Long, Master

Role: CONTACT

longjinhua100@sina.cn

0851-86512802

Facility Contacts

Jinhua Long, Master

Role: primary

longjinhua100@sina.cn

085186512802

Other Identifiers

201805045

Identifier Type: -

Identifier Source: org_study_id