Clinical trial NCT03723343: GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma
Official title: Prospective Phase II Clinical Study of GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Nasopharyngeal Carcinoma
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nasopharyngeal carcinoma with a distance between 18 and 65

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.

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.

   -

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. -

Primary outcomes:
measure: Progress-free survival(PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3 years
measure: Locoregional failure-free survival(LRFS)
timeFrame: 3 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 3 years
measure: Overall response rate
timeFrame: 3 years
measure: Incidence of acute and late toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: Guizhou Provincial Cancer Hospital
name: Jinhua Long, Master
role: PRINCIPAL_INVESTIGATOR
References: