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

Phase 3

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

• Registration Number: NCT03604965
• Lead Sponsor: Guiyang Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-21
• Study First Submitted: 2018-07-21
• Study First Submitted QC: 2018-07-21
• Last Update Submitted: 2018-07-21
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP+CCRT	GP+CCRT	GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy
TPF+CCRT	TPF+CCRT	TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy

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
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.
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.
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
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, 贵州省, China