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GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

A Multicenter, Randomized Controlled Phase III Clinical Trial of GP Induction Chemotherapy With TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma

NCT03604965•Guiyang Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Key Dates

Start Date

July 21, 2018

Primary Completion Date

July 21, 2020

Completion Date

July 21, 2020

Last Updated

July 30, 2018

Enrollment

204

ESTIMATED participants

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Interventions

GP+CCRT

DRUG

TPF+CCRT

DRUG

Contacts

Feng Jin, Bachelor

CONTACT

0851-86512802 jinf8865@yeah.net

Yuanyuan Li, Master

CONTACT

0851-86512802 lilyuanyuan@qq.com

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.

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