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

NCT ID: NCT03604965

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-21
• Study Completion Date: 2020-07-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GP+CCRT

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

Group Type: EXPERIMENTAL

GP+CCRT

Intervention Type: 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

TPF+CCRT

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

Group Type: ACTIVE_COMPARATOR

TPF+CCRT

Intervention Type: 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

Interventions

GP+CCRT

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

Intervention Type: DRUG

TPF+CCRT

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

Intervention Type: DRUG

Other Intervention Names

Experimental group; Control group

Eligibility Criteria

Inclusion Criteria

1. In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.

2. Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).

3. III, IVa patients (AJCC version 8 staging).

4. Male or non-pregnant women.

5. Age ≥ 18 and < 70 years old.

6. Functional status: Karnofsky scale (KPS) > 70.

7. 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)

8. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.

9. Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.

10. The patient has signed an informed consent form.

Exclusion Criteria

1. The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.

2. Age ≥ 70 years old or < 18 years old.

3. Treatment is palliative.

4. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.

5. Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).

6. Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).

7. Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guiyang Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Jing

Head and neck cancer director, chief researcher, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuanyuan Li, Master

Role: PRINCIPAL_INVESTIGATOR

Guizhou Provincial Cancer Hospital

Locations

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Feng Jin, Bachelor

Role: CONTACT

jinf8865@yeah.net

0851-86512802

Yuanyuan Li, Master

Role: CONTACT

lilyuanyuan@qq.com

0851-86512802

Facility Contacts

Yuanyuan Li, master

Role: primary

lilyuanyuan@qq.com

085186512802

Other Identifiers

201805043

Identifier Type: -

Identifier Source: org_study_id