GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

NCT03604965 | Unknown Phase 3 DMC

• 1 other identifier: 201805043
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.

Conditions

Locally 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)

GP+CCRT

EXPERIMENTAL

GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

Drug: GP+CCRT

TPF+CCRT

ACTIVE COMPARATOR

TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

Drug: TPF+CCRT

Interventions

GP+CCRT DRUG

Patients receive Neoadjuvant gemcitabine (1000mg/m2 on day1 and day8 ) and cisplatin (80mg/m2 on day1)every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy

Also known as: Experimental group

GP+CCRT

TPF+CCRT DRUG

Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy

Also known as: Control group

TPF+CCRT

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.
• Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
• III, IVa patients (AJCC version 8 staging).
• Male or non-pregnant women.
• Age ≥ 18 and \< 70 years old.
• Functional status: Karnofsky scale (KPS) \> 70.
• White blood cells (WBC) ≥ 4 × 109.
• /L, hemoglobin (HGB) ≥ 90 g / L, platelets (PLT) ≥ 100 × 109 / L (or within the normal range of the laboratory)
• Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
• Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.
• The patient has signed an informed consent form.

You may not qualify if:

• The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
• Age ≥ 70 years old or \< 18 years old.
• Treatment is palliative.
• Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
• Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
• Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).
• Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).
• With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose \> 1.5 × ULN),And mental illness.

Sponsors & Collaborators

• Guiyang Medical University: lead

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yuanyuan Li, Master

  Guizhou Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

0851-86512802; jinf8865@yeah.net

Yuanyuan Li, Master

CONTACT

0851-86512802; lilyuanyuan@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and neck cancer director, chief researcher, clinical professor

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: July 30, 2018
• Study Start: July 21, 2018
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)