Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced...
Stomach NeoplasmsTo determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine. Secondary endpoints are time to progression, overall response rate and overall survival. Study treatment will continue until disease progression or unacceptable toxicity.
Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients
Gastric CancerSince it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.
Phase I/II Study of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in...
Advanced Gastric CancerIn spite of multiple attempts to improve the efficacy of first-line chemotherapy in advanced gastric cancer, the progress that has been achieved so far is rather limited, and many investigators are exploring newer regimens.A combination of decetaxel (Taxotere) with Cisplatin and 5-fluorouracil (5FU) is considered one of the most effective regimens in this disease. However, it is associated with significant toxicity which avoided its general adaptation by the medical community. The current study is exploring a newer way to administer these three drugs, hopefully making the regimen more comfortable, less toxic and maybe even more effective. We will do this by changing the dose and timing of Taxotere and Cisplating, by replacing protracted infusion of 5FU with tablets of Capecitabine (Xeloda) and by adding the anti-angiogenic drug, Bevacizumab (Avastin), which had shown encouraging results in this disease.
An Effective and Well-Tolerated Regimen of Docetaxel Plus High-Dose 5-Fluorouracil and Leucovorin(HDFL)to...
Stomach NeoplasmsThe primary endpoint of this phase II trial is the objective tumor response rate. The secondary endpoints include treatment-related toxicity, the clinical benefit response defined by the change in performance status and body weight, the change in quality of life, progression free survival and overall survival. Simon's optimal two-stage design will be used to determine the patient number.
Study of Cetuximab Plus P-HDFL for the First-Line Treatment of Advanced Gastric Cancer
Stomach NeoplasmsThe primary end point of the study is confirmed objective response rate (complete response [CR] and partial response [PR]). A response rate of 80 percent for cetuximab plus cisplatin and weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (P-HDFL) chemotherapy is assumed. The Simon two-stage design will be used for P1 - P0 = 0.20. The response rates of interest are P0 = 60% and P1 = 80%. The investigators will reject cetuximab plus P-HDFL chemotherapy if the response rate is 8/13 at the first stage, and will reject the cetuximab plus P-HDFL chemotherapy if the response rate is 25/35 at the second stage. If there are more than 8 responses in 13 patients in the first stage, the study will continue to a total of 35 patients in the second stage. If there are more than 25 responses in 35 patients in the second stage, this treatment will be acceptable with a p-value of 0.05 and of 0.20. Evaluable patients for response will be those who received at least 4 doses of cetuximab (i.e. one cycle of protocol treatment). All enrolled patients will be subjected to toxicity evaluations. The primary end point of the study is confirmed objective response rates (by RECIST, Response Evaluation Criteria in Solid Tumors). The secondary end points of the study are progression-free survival, overall survival, and treatment-related toxicities. The analysis of response to treatment will be restricted to the eligible patients with at least one measurable lesion. The safety analysis will be restricted to the patients who received at least one cycle of the administered chemotherapy. The time-to-event end points will be estimated using the method of Kaplan and Meier and based on the intent-to-treat principle. Overall survival will be defined as the time interval between the date of study entry and the date of death. Progression-free survival will be defined as the time interval between the date of study entry and the date of disease progression or death, whichever occurred first. Duration of response will be defined as the time interval between the date of initial objective response and the date of disease progression, which is only for responders. If the event is not yet observed at the time of the last record, the patient will be censored at that time point.
Hyperthermia/Thermal Therapy With Chemotherapy to Treat Inoperable or Metastatic Tumors
Neuroendocrine CancerSmall Cell Lung Cancer2 moreThermal therapy (hyperthermia, or heat) increases chemotherapy cancer cell kill. By itself, thermal therapy can also kill cancer cells. Whole body thermal therapy is a systemic treatment; whole-body fever-range thermal therapy can safely treat cancer cells wherever they are throughout the entire body. In this study, we are testing the combination of fever-range heat treatment and chemotherapy to test 1) The response of three types of cancer (small-cell lung, neuroendocrine cancer, lung cancer, and gastric cancer) to the thermo-chemotherapy improves cancer response compared to the effect of only chemotherapy drugs in current use; 2) whether the thermo-chemotherapy treatment helps the person's own body fight the cancer cells; and 3) whether this treatment is safe and comfortable for the patient. This study does not offer heat treatment alone. Any patient with inoperable or metastatic small cell lung cancer, neuroendocrine cancer (any organ), gastric cancer, or lung cancer, can be treated with the Phase II protocol therapy; however, the patient will need to undergo selected medical tests to make sure this treatment would be safe for them.
Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients...
Gastric CancerRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach.
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or...
Colorectal CancerEsophageal Cancer2 moreRATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer. PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.
A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
Gastric CancerNowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy. Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.
Clinical Safety and Preliminary Efficacy of MUC1-DC-CTL Treatment in Stage IV Gastric Cancer.
Gastric CancerIn this study, safety and effects of MUC1-gene-DC-CTL and MUC1-peptide-DC-CTL on human gastric cancer are going to be investigated.