Neoplasms

All Conditions

Digestive System Diseases

Heart and Blood Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Embolism

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Chlorotrianisene

Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.

The first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1.

The second and fourth cycles: intra-venous oxaliplatin 135mg/m2, day 1.

Oral S-1, 40mg-60mg, day 1-14 for four 21-day cycles.

Teysuno

In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1.

Transarterial chemoembolization (TACE)

Zhaoqing Tang

This is a prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction.

The TACiE protocol includes four cycles. Transcatheter oxaliplatin and concurrent embolism on day 1 and oral S-1 on day 1-14 will be administrated in the first and third cycles. Intra-venous oxaliplatin on day 1 and oral S-1 on day 1-14 (SOX) will be administrated in the second and fourth cycles.

The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, many clinical trials have shown the benefit of perioperative treatment to gastric cancer patients. The neoadjuvant treatment is one of the most important parts.

Besides chemotherapy and chemoradiotherapy, the report of transcatheter arterial infusion (TAI) or transcatheter arterial embolism (TAE) in gastric cancer is relatively limited, though some case reports have showed its efficacy and safety in advanced gastric cancer. The combination of TAI and TAE (TACiE) may be more perspective in the treatment of gastric cancer. With transarterial infusion chemotherapy, TACiE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACiE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity.

Based on those knowledges, we designed this prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACiE. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.

Neoadjuvant TACiE in Locally Advanced Gastric Cancer

Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Prospective, Phase 2, Single Arm Trial.

The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.

The percentage of patients found less than 10% tumor residual in primary tumor.

The percentage of patients found complete response or partial response to preoperative therapy according to RECIST v1.1.

The time from enrollment to death caused by any causes or censor.

The time from enrollment to tumor progression, death or censor.

Shanghai Zhongshan Hospital

Gland and Hormone Related Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Pancreatic Neoplasms

Cardiotoxicity

Bile Duct Neoplasms

Neoplasms, Unknown Primary

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Neoplasm Metastasis

Neoplastic Processes

Pancreatic Cancer

Tegafur

Capecitabine

Antimetabolites

Capecitabine 1250 mg/m2 twice daily, days 1-14 every 21 days

Capecitabine 1000 mg/m2 twice daily, days 1-14 every 21 days (in frail or elderly patients, a CAP dose of 750 mg/m2 BD should be considered). Oxaliplatin will be given as an iv infusion at a dose of 130 mg/m2 over 2-6 hours on day 1.

Teysuno will be administered at a dose of 30 mg/m2 twice daily, for 14 days, with a subsequent 7-day rest period. Patients will be assigned a dose on the basis of body surface area (BSA) and will receive one of the following doses twice daily: 40mg (BSA \< 1.5 m2), 45 mg (BSA 1. 5 to \< 1.7 m2), 55mg (BSA 1.7 - 1.9 m2),

Teysuno will be administered orally at a dose of 25mg/m2 twice daily, days 1-14 every 21 days Patients will be assigned a dose on the basis of body surface area (BSA) and will receive one of the following doses twice daily: 35mg (BSA \< 1.5 m2), 40mg (BSA 1.5 to \< 1.7 m2), 45mg (BSA 1.7 - 1.9 m2), 50mg (BSA \>1.9 m2). Oxaliplatin will be given as an iv infusion at a dose of 130 mg/m2 over 2-6 hours on day 1.

Sally Clive, MBChB

Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems including heart attacks. An alternative drug, called teysuno is used extensively in other countries instead of capecitabine and appears to have less of a bad effect on the heart whilst still killing cancer cells. This study will investigate the effect of these two drugs on the heart and blood vessels and will be the first of its kind in humans.

Fluoropyrimidines (FPs) are widely used chemotherapy agents for the management of patients with colorectal, breast, upper gastrointestinal, head and neck cancers. Capecitabine is an oral prodrug of 5-fluorouracil (5FU) which is used extensively in the UK but is associated with clinically overt cardiotoxicity in up to 9% of patients. Cardiotoxicity occurs more commonly in patients with cardiovascular disease and manifests as chest pain, myocardial infarction, congestive heart failure, or sudden death with a mortality as high as 30%. In a study of continuous ECG Holter monitoring in patients receiving 5FU infusion, the majority (68%) of patients had ischaemic ECG changes and 2 patients died suddenly. We conducted a national survey of UK oncologists and 60% felt that 5FU/capecitabine cardiotoxicity was a significant problem in their clinical practice.

Hypotheses for this toxicity include ischaemia secondary to coronary artery spasm, direct endothelial cell toxicity, myocardial toxicity and interactions with the coagulation system. Studies implicate a catabolite of 5FU, in particular fluoro-alanine (FBAL). FBAL is further metabolized to fluoroacetate (FAC), a cardiac toxin that inhibits mitochondrial aconitase, resulting in cell death.

Teysuno is an oral fluoropyrimidine that has recently obtained a European licence. It is a combination of tegafur (5-FU prodrug), gimeracil (dihydropyrimidine dehydrogenase (DPD) inhibitor) and oteracil (phosphorylation inhibitor). There have been no reports of cardiac toxicity with teysuno. The incorporation of a DPD inhibitor should reduce FBAL concentrations which may prevent FP cardiotoxicity. However, this remains to be established.

Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine

Toxicity OF Fluoropyrimidines: A Comparative Study of the Cardiotoxicity of capEcitabine and tEysuno

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) will be shared with other researchers on request

This will be recorded using Del Mar Reynolds Lifecard CF/Lifecard 12 recorders, which will record 12 leads over 24 hours and continuously if the storage card is changed daily. Pre-treatment control ECGs will be recorded for 24 hours. Continuous 12-lead monitoring shall be recorded for three days between day 5 and 7 of treatment.

NHS Lothian

University of Edinburgh

Preoperative transcatheter arterial chemoinfusion and embolism (TACiE) alternated with systemic chemotherapy.

Oral S-1, 40mg-60mg bid, day 1-14 for four 21-day cycles.

In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1, if applicable.

Transarterial arterial chemoinfusion and embolism (TACiE)

This is a prospective pilot study to evaluate the safety and feasibility of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction.

The TACiE protocol includes four cycles. Transcatheter oxaliplatin and concurrent embolism on day 1 and oral S-1 on day 1-14 will be administrated in the first and third cycles. Intra-venous oxaliplatin on day 1 and oral S-1 on day 1-14 (SOX) will be administrated in the second and fourth cycles.

A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer

Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Pilot Study

The percentage of patients who developed TRAE

Esophageal Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Head and Neck Neoplasms

Esophageal Diseases

Rectal Diseases

Esophageal Cancer

Small Intestine Cancer

Oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14.

Intravenous oxaliplatin 130 mg/m2 d.1 followed by oral capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14.

S-1 25 mg/m2/day BID d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks

capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks

Heikki Joensuu, MD

Fluoropyrimidine chemotherapy agents , such as 5-fluorouracil and capecitabine, are occasionally associated with cardiac toxicity. Clinical fluoropyrimidine cardiotoxicity is infrequent, but subclinical toxicity may be much more common. Cardiac toxicity may be less frequent with S-1 as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking. The purpose of the study is to compare 2 measures of subclinical coronary artery microvascular dysfunction, the coronary flow reserve and the coronary flow response to a cold pressor test, in a patient population who are being treated for adenocarcinoma of the gastrointestinal tract with one of 2 oxaliplatin-containing regimens, either with oxaliplatin plus S-1 or with oxaliplatin plus capecitabine.

Patients diagnosed with adenocarcinoma of the gastroesophageal tract are randomly assigned to receive two 3-weekly cycles of either XELOX (intravenous oxaliplatin 130 mg/m2 d.1 followed by oral capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14) or SOX (intravenous oxaliplatin 130 mg/m2 d. 1 followed by oral S-1 25 mg/m2/day BID d1-14). A cross-over between the 2 arms is carried out after the first 2 cycles; patients allocated to XELOX will receive 2 cycles of SOX (cycles 3 and 4), and those allocated to SOX will receive XELOX (cycles 3 and 4). Monitoring of the coronary artery flow, cardiac arrythmias, cardiac symptoms and blood biochemistry is done at baseline, during each chemotherapy cycle (cycles 1 to 4) and after treatment.Study treatment will continue until all patients have discontinued from treatment or maximum 24 weeks from the date of the first day of treatment, whichever occurs first. At that point, treatment may continue at the discretion of the Investigator. Each patient will be followed for survival status for a minimum of 12 months after first dose of study medication. Tumor assessments will be performed throughout the study period and analyzed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009). Computed tomography (CT) scans will be performed at the end of every 2 cycles. Cardiac assessments will be performed and analyzed using non-invasive transthoracic Doppler echocardiography, 24-h Holter registration, and plasma troponin concentration.

Effects of S-1 and Capecitabine on Coronary Artery Blood Flow

Effects of S-1 and Capecitabine in Combination With Oxaliplatin on the Coronary Artery Blood Flow in Patients Metastatic Gastrointestinal Tract Adenocarcinoma: a Randomized Phase II Study

The frequency of subclinical coronary artery dysfunction is as assessed by comparing the coronary flow reserve during chemotherapy with the baseline coronary flow reserve, and the coronary flow response to a cold pressor test.

The coronary artery blood flow rate is measured with ultrasound. The rates are compared with the baseline and between the groups.

Cardiac arrythmias detected with Holter cardiac recording.

Survival from the first dose of study medication to study completion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant TACiE in Locally Advanced Gastric Cancer	NCT05346874	Gastric Cancer	Oxaliplatin Teysuno Transarterial c...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine	NCT01845337	Gastrointestina... Cancer of Unkno... Pancreatic Canc... Bile Duct Neopl...	Teysuno Capecitabine	18 Years - 100 Years	University of Edinburgh
A Pilot Study of Neoadjuvant TACiE in Locally Advanced Gastric Cancer	NCT05396326	Gastric Cancer	Oxaliplatin Teysuno Transarterial a...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Effects of S-1 and Capecitabine on Coronary Artery Blood Flow	NCT02216149	Esophagus Cance... Stomach Cancer Small Bowel Can... Colon Cancer Rectum Cancer	S-1 Capecitabine Oxaliplatin	18 Years - 100 Years	Helsinki University Central Hospital
Effects of S-1 and Capecitabine on Coronary Artery Blood Flow	NCT02216149	Esophagus Cance... Stomach Cancer Small Bowel Can... Colon Cancer Rectum Cancer	S-1 Capecitabine Oxaliplatin	18 Years - 100 Years	Helsinki University Central Hospital
Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine	NCT01845337	Gastrointestina... Cancer of Unkno... Pancreatic Canc... Bile Duct Neopl...	Teysuno Capecitabine	18 Years - 100 Years	University of Edinburgh

Spots Global Cancer Trial Database for teysuno

Every month we try and update this database with for teysuno cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for teysuno

Every month we try and update this database with for teysuno cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for teysuno cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.