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

Docetaxel

Cisplatin

Nedaplatin

Tubulin Modulators

Antimitotic Agents

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT)

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT)

neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT)

neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT)

neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy

concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy

nedaplatin and docetaxel

neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy

concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy

cisplatin and docetaxel

Wang R Sheng, M.D.

Wu Fang, M.D.

Wang R. sheng, M.D.

Wang R sheng, M.D.

This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.

Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy（IMRT）group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Acute toxicity will be measured by CTCAE3.0

1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival

Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E).

People's Hospital of Guangxi

303rd Hospital of the People's Liberation Army

Nanning Second People's Hospital

Guangxi Traditional Chinese Medical University

Guilin Medical College

Guangxi Naxishan Hospital

Liuzhou Workers Hospital

LiuZhou People's Hospital

Liuzhou Hospital of Traditional Chinese Medicine

Liuzhou Cancer Hospital

Liuzhou Railway hospital

First People's Hospital of Yulin

The Red Cross hospital of YuLin

Guigang People's Hospital

Wuzhou Red Cross Hospital

Guangxi Medical University

Director

Digestive System Diseases

Esophageal Neoplasms

Adenocarcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery

cisplatin and docetaxel chemo- and radiochemotherapy

Cisplatin and Docetaxel

Thomas Ruhstaller, MD

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.

OBJECTIVES:

Primary

* Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer.
* Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients.

Secondary

* Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results.
* Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
* Determine the clinical benefit of this regimen in these patients.

OUTLINE: This is a multicenter study.

* Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22.
* Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks.
* Surgery: Patients undergo surgery 3-8 weeks after the final administration of radiotherapy.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study.

Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial

Swiss Group for Clinical Cancer Research

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

concurrent and adjuvant chemotherapy with cisplatin and docetaxel combined radical radiotherapy.

During external beam radiotherapy: cisplatin 60mg/m2, d1,d22; docetaxel 60mg/m2, d1,d22.

After external beam radiotherapy: cisplatin 75mg/m2, d43,d64;

The patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.

docetaxel 75mg/m2, d43,d64.

standard chemoradiotherapy with weekly cisplatin.

Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.

Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.

in experimental group: cisplatin 60mg/m2, d1,d22;

concurrent chemotherapy with cisplatin

in experimental group: docetaxel 60mg/m2, d1,d22;

concurrent chemotherapy with docetaxel

external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.

pelvic radiotherapy

CT/MRI guided brachytherapy or x-ray guided brachytherapy

brachytherapy

cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64

adjuvant chemotherapy with cisplatin and docetaxel

mei shi, professor

ying zhang, doctor

Mei Shi, professor

Mei Shi, MM

Mei Shi, MD

The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.

The cervical cancer is the most common malignant gynecological tumor in the developing area. From 1999, the concurrent chemoradiotherapy has been established as the standard treatment for local advanced cervical cancer. The modern radiotherapy techniques, such as 3 dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical cancer. The recently clinical outcome showed that the 3 year local and regional control was more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and death, especially for the patient with pelvic lymph node metastasis, large volume of tumor and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant metastasis has become to be the topic of clinical investigation.

Dueñas-González A'［4］ study demonstrated that the 3 year progress free survival and distant metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant chemotherapy after CCRT has better DMFS and OS.

The aim of present study is to prospectively investigate the efficacy and safety of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.

Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer

Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer

Air Force Military Medical University, China

chair of department

Nutritional and Metabolic Diseases

Malnutrition

Nutrition Disorders

Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)

NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses.

CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT).

Dietary supplement: enteral nutrition and parenteral nutrition

Chong Zhao, M.D

This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。

Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Effect of Neoadjuvant Chemotherapy Followed by Concurrent Chemo-radiotherapy on Nutritional Status in Locoregionally Advanced Nasopharyngeal Carcinoma Patients: Prospective Observational Study

To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 3.0 when adjuvant chemotherapy and concurrent chemoradiation is used.

To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.

Using European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30(version 3.0) and EORTC QLQ-H\&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 4/5 cycles of chemotherapy, 3 years after all treatment finished.

To evaluate the late toxicity with the SOMA criterion after 1/2/3 years of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma	NCT01479504	Nasopharyngeal ...	nedaplatin and ... cisplatin and d... nedaplatin and ... cisplatin and d...	18 Years - 70 Years	Guangxi Medical University
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer	NCT00072033	Esophageal Canc...	Cisplatin and D...	18 Years - 70 Years	Swiss Group for Clinical Cancer Research
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer	NCT02703961	Cervical Cancer	concurrent chem... concurrent chem... pelvic radiothe... brachytherapy adjuvant chemot...	18 Years - 60 Years	Air Force Military Medical University, China
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer	NCT00072033	Esophageal Canc...	Cisplatin and D...	18 Years - 70 Years	Swiss Group for Clinical Cancer Research
A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma	NCT01479504	Nasopharyngeal ...	nedaplatin and ... cisplatin and d... nedaplatin and ... cisplatin and d...	18 Years - 70 Years	Guangxi Medical University
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer	NCT02703961	Cervical Cancer	concurrent chem... concurrent chem... pelvic radiothe... brachytherapy adjuvant chemot...	18 Years - 60 Years	Air Force Military Medical University, China
Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients	NCT02575547	Nasopharyngeal ... Malnutrition	cisplatin and d...	18 Years - 65 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for cisplatin and docetaxel