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

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: GP+IMRT; Drug: TPF+IMRT

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.

• Study Type: Observational
• Enrollment (Anticipated): 146

Contacts and Locations

• Study Contact: Name: Jinhua Long, Master; Phone Number: 0851-86512802; Email: longjinhua100@sina.cn

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Cancer Hospital of Guizhou Medical University
      • Contact: Jinhua Long, Master; Phone Number: 085186512802; Email: longjinhua100@sina.cn
      • Principal Investigator: Feng Jin
      • Principal Investigator: Weili Wu
      • Principal Investigator: Yuanyuan Li
      • Principal Investigator: hong Tang
      • Principal Investigator: Xiuling Luo
      • Principal Investigator: Xiuyun Gong
      • Principal Investigator: Xiaoxiao Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Nasopharyngeal carcinoma with a distance between 18 and 65

Description

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. -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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; Other Names: Experimental group
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	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; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress-free survival(PFS)	Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.	3 years
Locoregional failure-free survival(LRFS)	The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.	3 years
Distant metastasis-free survival(DMFS)	The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.	3 years
Incidence of acute and late toxicity	Incidence of acute toxicity（Grade1/2/3/4） is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme	3 years
Overall response rate	Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1	3 years

Collaborators and Investigators

• Sponsor: Guiyang Medical University
• Investigators: Principal Investigator: Jinhua Long, Master, Guizhou Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 18, 2018
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: 201805045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes