Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nimotuzumab

Cisplatin

Antineoplastic Agents, Immunological

TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

TPF regimen induction chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy

TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Feng Jin, Bachelor

Weili Wu, master

Weili Wu, Master

Yuanyuan Li, master

Jinhua Long, master

Xiuyun Gong, bachelor

Xiaoxiao Chen, bachelor

Yu Chen, master

This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.

TPF program is currently the local advanced nasopharyngeal carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients.In this study, Phase II clinical trials were performed. Patients with locally advanced local advanced nasopharyngeal carcinoma were nonrandomly divided into experimental group and control group.The trial group was treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and chemotherapy. The control group was treated with TPF regimen induction chemotherapy combined with Cisplatin concurrent radiotherapy and chemotherapy.observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC

Prospective, Multicenter, and Nonrandomized Phase II Clinical Study on the Treatment of Locally Advanced NPC By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy

Acute toxicity of radiotherapy and chemotherapy

Evaluation of efficacy by RESIST1.1 standard

Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST

Guiyang Medical University

Head and neck cancer director, chief researcher, clinical professor

Digestive System Diseases

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Gemcitabine

Induction chemotherapy (IC) + Concurrent chemoradiotherapy (CCRT) and enteral immunonutrition

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2-3 cycles before radiotherapy and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin (100mg/m² d1) every 3 weeks for 2-3 cycles.

Patients receive enteral immunonutrition, Oral Impact®, Nestle, 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.

Induction chemotherapy+Concurrent chemoradiotherapy and standard enteral nutrition

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2-3 cycles before radiotherapy and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin(100mg/m² d1) every 3 weeks for 2-3 cycles.

Patients receive isocaloric standard enteral nutrition formula (ENSURE®), 250 mL per administration, 3 times per day, from 5 days before radiotherapy to the end of radiotherapy. Preparation of the 250 mL dose involves adding 200 mL of potable water to a cup and slowly stirring in 52.7 g of ENSURE powder (approximately 6 scoops).

Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.

Enteral immunonutrition

Isocaloric standard enteral nutrition formula (ENSURE®)， 250 mL per administration, 3 times per day. Preparation of the 250 mL dose involves adding 200 mL of potable water to a cup and slowly stirring in 52.7 g of ENSURE powder (approximately 6 scoops).

Standard enteral nutrition

Min Kang, Ph.D

Zhen Meng, Ph.D

The purpose of this study was to investigate the role of immunonutrion compared with standard nutrition in reducing oral mucositis in patients with locally advanced nasopharyngeal carcinoma.

Oral mucositis is the most common adverse reaction in patients with nasopharyngeal carcinoma receiving chemoradiotherapy, of which 40-50% of patients are severe (grade 3-4). Oral mucositis usually results in pain, dysphagia, reduced feeding, and malnutrition. Severe malnutrition in turn increases the risk of severe oral mucositis. Persistent severe oral mucositis will lead to delay and interruption of treatment, impairing patients'quality of life and prognosis. It's reported that nutritional intervention can not only reduce the risk and severity of oral mucositis and improve the nutritional status of patients with head and neck tumors, but also improve patients' tolerance to radiotherapy, quality of life, and prognosis.

Immunonutrition refers to the addition of high content of immune nutrients on the basis of sufficient calories, which not only ensures the supply of nutrition, but also takes into account the effects of anti-inflammation, regulating immunity, improving treatment tolerance, improving prognosis and so on. It has been reported that, comparing with standard enteral nutrition, the incidence of severe oral mucositis and esophagitis in patients with head and neck tumors treated with immunonutrition was lower, suffering less weight loss, and the antitumor immune response was enhanced. The 3-year OS and PFS were significantly improved in patients with good compliance.

It remains to be seen whether or not NPC patients receiving chemoradiotherapy can be benifit from immunonutritional therapy. Therefore, we conducted a prospective, multi-center, randomized controlled clinical study in patients with nasopharyngeal carcinoma who received radiotherapy and chemotherapy without metastases, to further improve the quality of life and prognosis of patients with nasopharyngeal carcinoma.

Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy

Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Total duration from the start of radiotherapy to the severe oral mucositis

The number of days of severe oral mucositis during the oral mucositis observation period

Change in high sensitivity C-reactive protein from baseline to end of radiotherapy

Change in serum level of Interleukin-6 from baseline to end of radiotherapy

Change in hemoglobin level from baseline to end of radiotherapy

Change in nutritional risk determined by the by the nutrition risk screening-2002 (NRS-2002) from baseline to end of radiotherapy

Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) from baseline to end of radiotherapy

Changes in handgrip strength from baseline to end of radiotherapy

EORTC QLQ-C30 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. A EORTC QLQ-C30 is a specific quality of life assessment scale, with 30 items. All of the scales and single-item measures range from 0 to 100. More global and functional scales is better. less symptom scales is better.

EORTC QLQ-H\&N35 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 35 items. All of the scales and single-item measures range from 0 to 100. High scores represent increased (worse) symptoms.

Analysis of acute and late adverse events (AEs) are evaluated.

Guangdong Provincial People's Hospital

Zhejiang Cancer Hospital

Zhejiang Provincial People's Hospital

Fujian Cancer Hospital

Fujian Provincial Hospital

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

The First Affiliated Hospital of Nanchang University

Second Affiliated Hospital of Nanchang University

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Qingdao Central Hospital

Huizhou Municipal Central Hospital

Haikou People's Hospital

The Second Affiliated Hospital of Hainan Medical University

Zhejiang Provincial Tongde Hospital

Guilin Medical University, China

Liuzhou Workers Hospital

Wuzhou Red Cross Hospital

Red Cross Hospital of Yulin City

First Affiliated Hospital of Guangxi Medical University

Professor

Docetaxel

Fluorouracil

2 cycles induction + concurrent chemoradiotherapy

3 cycles induction + concurrent chemoradiotherapy

Drug: 2 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.

Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w.

Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

2 cycles induction chemotherapy

Drug: 3 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.

Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w.

Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

3 cycles induction chemotherapy

Cheng-Tao Wang

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

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

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

Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.

First Affiliated Hospital, Sun Yat-Sen University

Prof.

Nivolumab

Immune Checkpoint Inhibitors

Dosage within 12 weeks after the end of concurrent chemoradiation therapy. Nivolumab 360mg Intravenously administered every 3 weeks.

As a consolidation regimen, administration of Nivolumab is administered for up to a total of 1 year until disease progression or unacceptable to toxicity occurs.

Hye Ryun Kim

The clinical efficacy of nivolumab for locally advanced nasopharyngeal carcinoma patients with residual disease after standard chemoradiotherapy is not known. In this study, we aim to investigate the role of nivolumab in locally advanced NPC after chemoradiotherapy the safety profile and antitumor activity of the anti-programmed death 1 (PD-1) receptor monoclonal antibody, nivolumab after in patients with advanced nasopharyngeal carcinoma

A Phase 2, Open-label Trial of Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Progression-free survival rate at 2 years, which is the primary endpoint, will be measured by the proportion of patients who remain progression-free after 2 years of study registration.

Overall survival will be followed continuously while subjects are on the study drug and every 6 months after discontinuation or progression for up to 5 years following the start of therapy either by direct contact (office visits) or via telephone contact, until death, withdrawal of study consent, or lost to follow-up.

The procedures and assessments may be performed as part of standard of care; however, data for these assessments should remain in the subject's medical record and should not be provided to Ono unless specifically requested. NCI CTCAE Version 5.0 will be the criteria used to assess adverse events.

To understand correlated expressions of protein markers related to therapy response, multiplexed-image analysis (Vectra Polaris® and inForm®, PerkinElmer) is applied in tumor tissues

Analysis of gene expression profile and immune markers with tissue and peripheral blood

Soluble factor analysis with blood: Cytokines related to adaptive immune responses, chemokines, and VEGF will be analyzed using the Cytometric Bead Assay (CBA) from serially collected plasma samples.

Yonsei University

Cetuximab

2 cycles of neoadjuvant cisplatin and 5FU (3 weekly), given with weekly cetuximab, followed by 7 doses of weekly cisplatin and cetuximab concurrent with radiotherapy

Cetuximab loading dose of 400mg/m2, then weekly dose of 250mg/m2 for 12 doses; Neoadjuvant Cisplatin 75mg/m2 D1, 5FU 1000mg/m2 D2-5, for 2 cycles; Concurrent Cisplatin 30mg/m2 given with radiation 70Gy/35fraction/7weeks.

Gwo Fuang Ho, FRCR

Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.

Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma

Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings

Merck Serono International SA

University of Malaya

Medical Lecturer

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

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

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

GP+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

TPF+CCRT

Yuanyuan Li, Master

Jinhua Long, Master

Xiuling Luo, Bachelor

Xiuyun Gong, Bachelor

Yanfang Cen, Bachelor

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.

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

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.

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.

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.

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.

Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1

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

Substance Related Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Tubulin Modulators

Antimitotic Agents

radiotherapy combined with Chemotherapy Drugs, Cancer

This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.

Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma

the General Hospital of PLA

incidence rate of the toxic reaction between three groups

differences of over survival rate between three groups

Luo yanrong

Clinical Doctor

Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.

Induction Chemotherapy

Concurrent Chemotherapy

For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

Definitive Radiotherapy

Shuang Wu, PHD

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

Defined as the time from randomization to local or regional recurrence. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence free. Patients not having an event will be censored at the date last seen alive.

Defined as the time of randomization to the appearance of distant metastasis. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and metastasis free. Patients not having an event will be censored at the date last seen alive.

Adverse events during the treatment period will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Late AE of radiotherapy will be assessed according to RTOG criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC	NCT03557112	Nasopharyngeal ...	Nimotuzumab Cisplatin	18 Years - 70 Years	Guiyang Medical University
Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy	NCT05892354	Locally Advance...	Enteral immunon... Standard entera...	18 Years - 70 Years	First Affiliated Hospital of Guangxi Medical University
Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma	NCT05860868	Locally Advance...	2 cycles induct... 3 cycles induct...	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University
A Phase 2, Open-label Trial of Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma	NCT04910347	Locally Advance...	Nivolumab	19 Years -	Yonsei University
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma	NCT01230476	Nasopharyngeal ...	Cetuximab	18 Years - 65 Years	University of Malaya
GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC	NCT03604965	Locally Advance...	GP+CCRT TPF+CCRT	18 Years - 69 Years	Guiyang Medical University
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma	NCT03177174	Drug-Related Si...	Cisplatin Docetaxel	18 Years - 70 Years	Chinese PLA General Hospital
ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma	NCT05062005	Locally Advance...	Induction Chemo... Concurrent Chem... Definitive Radi...	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for locally advanced nasopharyngeal carcinoma