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

• Conditions: Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: GP+IMRT; Drug: TPF+IMRT

• Registration Number: NCT03723343
• Lead Sponsor: Guiyang Medical University

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-18
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-26
• Last Update Submitted: 2018-10-26
• Study First Posted: 2018-10-29
• Last Update Posted: 2018-10-29
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: GP+IMRT	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
Active Comparator: TPF+IMRT	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

Primary Outcome Measures

Name	Time	Method
Progress-free survival(PFS)	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Distant metastasis-free survival(DMFS)	3 years	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.
Overall response rate	3 years	Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1
Locoregional failure-free survival(LRFS)	3 years	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.
Overall survival(OS)	3 years	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.
Incidence of acute and late toxicity	3 years	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

Trial Locations

Locations (1)

Cancer Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China