Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

oxaliplatin：65mg/m2,d1,8,22,29,I.V; capecitabine: 625mg/m2, bid d1-5; q1w, po,5 weeks in total; radiotherapy:50Gy,2 Gy/d,5d/w.

oxaliplatin:65mg/m2,d1,8,22, 29,43,50,64,71,I.V; capecitabine:625mg/m2,bid d1-5; q1w, po,10 weeks in total; radiotherapy:50Gy ,2 Gy/d,5d/w.

capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total

Capecitabine(Aibin)

Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,I.V. or Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,43,50,64,71,I.V.

Oxaliplatin(Aiheng)

concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity

Radiotherapy

Shegan Gao, Doctor

Tanyou Shan, Master

shegan gao, doctor

tanyou shan, master

Xiaoshan Feng, Doctor

Jiachun Sun, Doctor

Xinshuai Wang, Doctor

Guoqiang Kong, Master

Xiaozhi Yuan, Master

Ruinuo Jia, Master

Dan Zhou, Master

Jing Ren, Master

Ruina Yang, Master

Dan Wang, Master

Yongxuan Liu, Master

Yali Zhang, Master

Weijiao Yin, Master

Wei Wang, Master

Shiyuan Song, Master

A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive chemoradiotherapy is the standard regimen in Western countries for patients with esophageal cancer who can't receive surgery or reject surgery. But in China because of its severer toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to its characristic of low toxic reaction.

The purpose of this study is to confirm the efficacy and safety of the different cycles(two cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

First: The investigators use excel generate a 5 digits random number table. After subjects sign the informed consent, investigators will chose one for themm. Subject who get an odd number will receive 2cycles' chemotheapy concurrent radiotherapy and even number receive 4cycles'. Investigators should record the congruent relationship of subjects with group code.

Second: The investigators are required to record subjects' base measurements. The base measurements items:1.Tumor confirmed date,TNM staging,History of esophageal cancer treatment;2.Demographic data,past medical history;3.physical examination(a detailed system check including general neurological examination);4.vital signs,Height,Weight;5.PS score,Quality of life;6.serum biochemistry(ALT,AST,AKP,TBIL,blood glucose,BUN,Ccr,electrolyte,et al.);7. Blood RT(RBC,HGB,WBC,ANC,PLT,et al.);8.Urine routines;9.Endoscopic biopsy(More than 3 pieces of biopsy specimens),chest CT,abdomen ultrasound/CT/MRI,PET-CT,et al.;10.Blood/urine pregnancy tests;11.Collect blood samples(5 ml);12.Preserve CorpseSample. note:Check the time limit-2 weeks before get into groups.

Third:Observation items during treatment include 3-8 items of the base measurements;Radiotherapy 20 times, should review of esophageal barium meal or chest CT. The investigators need to observe adverse event during treatment and eveluate the relationship of adverse event with researched therapeutic regimen according to the Common Terminology Criteria for Adverse Events,CTCAE) (V4.0, 2009-05-28) and accurately fill in Case Report Form(CRF).

Fourth: Follow-up items include 3-9 items of the base measurements;bood and tissue sample should also be preserved when subject receives 16th weeks' review.

The patient who withdrew from the study during researched treatment must accept the end evaluation research. The investigators must record the reason and the date of termination in patient' progress note and CRF.

Cases of complete report should transfer to data administrators after investigates by clinical research associate. Data administrators input and management data.

The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy

Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial

The First Affiliated Hospital of Zhengzhou University

Xinyang Central Hospital

Anyang Tumor Hospital

No. 150 Central Hospital of the Chinese People Liberation Army

The First Affiliated Hospital of Henan University of Science and Technology

Symptoms and General Pathology

Stomach Neoplasms

Disease Progression

Stomach Diseases

Stomach Cancer

XELOX(Xeloda and oxaliplatin combination)

Capecitabine 1000mg/m2 Bid d1-14 Oxaliplatin 130mg/m2 d1 q3w

Capecitabine and Oxaliplatin

Jin Li, PhD

The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.

The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.

Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer

Fudan University

Base for drug clinical trials, Fudan University cancer hospital

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Fluorouracil

patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin

Capecitabine and Oxaliplatin will be under the NSCLC guideline

Dake Chu, M.D.

This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer.

This study will examine a new combination of drugs: Capecitabine and Oxaliplatinfor for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer. In the present trial, we will study the combination of these two drugs in patients with colorectal cancer among Chinese population

Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III

Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population

Tianjin Union Medical Center

Beihua University

Chengdu Medical College

Shanghai Jiao Tong University School of Medicine

State Key Laboratory of Cancer Biology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Sherry Morgan-Meadows

Both capecitabine and oxaliplatin have single agent activity in breast cancer. The combination has improved activity in other solid tumors. This study seeks to assess the activity of the combination in breast cancer.

XELOX for Metastatic Breast Cancer

A Phase II Trial of Capecitabine and Oxaliplatin in Metastatic Breast Cancer

Sanofi

University of Wisconsin, Madison

Micronutrients

Anti-Infective Agents

Docetaxel

Iodine

Tubulin Modulators

Antimitotic Agents

Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1

* Docetaxel 60 mg/m² will be intravenously infused over at least 1 hour on Day 1 every 3 weeks.
* Oxaliplatin 100 mg/m² will be intravenously infused over at least 2 hours on Day 1 every 3 weeks.
* Capecitabine 800 mg/m² will be orally administered twice daily from Day 1 evening to Day 15 morning every 3 weeks. (Total 1,600 mg/m² daily)

Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1

Docetaxel and capecitabine and oxaliplatin

capecitabine and oxaliplatin

Min-Hee Ryu, M.D.,Ph.D

Hyung-Don Kim, M.D.,Ph.D

Min-Hee Ryu, M.D., Ph.D.

Ryoo Back-Yeol, MD,PhD

Ryu Min-Hee, MD,PhD

Park Sook-Ryun, MD,PhD

multicenter, open label, randomaized, phase III

The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.

Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH

A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)

To compare 3-year disease-free survival (DFS) between the two groups. DFS is defined as the time from randomization date to objective tumor recurrence as assessed with the RECIST 1.1, onset of new gastric cancer, or death.

Overall survival (OS): Overall survival is defined as the time from randomization date to date of death by any cause. If death cannot be confirmed, survival time will be the last date when the subject's survival is confirmed or the date when the contact is lost, whichever comes first. For subjects lost to follow-up, the last contact date will be entered.

Safety evaluation: Type and severity of adverse events will be compared between the two groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy	NCT02604615	Stage III Esoph... Esophageal Neop...	Capecitabine(Ai... Oxaliplatin(Aih... Radiotherapy	45 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology
Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer	NCT00568529	Gastric Cancer	Capecitabine an...	18 Years - 70 Years	Fudan University
Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III	NCT01196260	Colorectal Canc...	Capecitabine an...	18 Years - 90 Years	State Key Laboratory of Cancer Biology
XELOX for Metastatic Breast Cancer	NCT00204776	Metastatic Brea...	Capecitabine an...	18 Years -	University of Wisconsin, Madison
The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy	NCT02604615	Stage III Esoph... Esophageal Neop...	Capecitabine(Ai... Oxaliplatin(Aih... Radiotherapy	45 Years - 75 Years	The First Affiliated Hospital of Henan University of Science and Technology
Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer	NCT00568529	Gastric Cancer	Capecitabine an...	18 Years - 70 Years	Fudan University
Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH	NCT01935778	Gastric Cancer,...	Docetaxel and c... capecitabine an...	20 Years - 75 Years	Asan Medical Center

Spots Global Cancer Trial Database for capecitabine and oxaliplatin