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

NCT03723343 | Unknown DMC

• 1 other identifier: 201805045
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival(OS)

  3 years

• Locoregional failure-free survival(LRFS)

  3 years

• Distant metastasis-free survival(DMFS)

  3 years

• Overall response rate

  3 years

• Incidence of acute and late toxicity

  3 years

Study Arms (2)

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

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

Interventions

GP+IMRT 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

Also known as: Experimental group

Experimental: GP+IMRT

TPF+IMRT 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

Also known as: Control group

Active Comparator: TPF+IMRT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Nasopharyngeal carcinoma with a distance between 18 and 65

You may qualify if:

• The pathological type is non-keratinized cancer (according to the pathological classification of the World Health Organization, WHO).
• The stage is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I).
• There is evidence of distant transfer (M1).
• functional status: Karnofsky scale (KPS) \> 70 (Appendix II).
• normal bone marrow function: white blood cell count \> 4 × 109 / L, hemoglobin \> 90g / L and platelet count \> 100 × 109 / L.
• 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.
• normal renal function: creatinine clearance (creatinine clearance) \> 60 ml / min.
• The patient must be informed of the basic content of the study and sign an informed consent form.

You may not qualify if:

• the pathological type is WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma.
• age \> 65 years old or \< 18 years old.
• a history of malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
• Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
• has received radiation therapy (if it is non-melanoma skin cancer and the previous lesion is placed
• Except for the target area of treatment.
• primary lesions and cervical metastases have received chemotherapy or surgery (except for diagnostic treatment).
• 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. -

Sponsors & Collaborators

• Guiyang Medical University: lead

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jinhua Long, Master

  Guizhou Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

0851-86512802; jinf8865@yeah.net

Jinhua Long, Master

CONTACT

0851-86512802; longjinhua100@sina.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and neck cancer director, chief researcher, clinical professor

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 29, 2018
• Study Start: October 18, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

CN (1)