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Colonic Neoplasms clinical trials

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NCT ID: NCT05833672 Not yet recruiting - Colon Cancer Clinical Trials

Neoadjuvant Immunotherapy in Locally Advanced Colon Cancers

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of neoadjuvant immunotherapy combined with chemotherapy before colonic resection in patients with locally advanced colon cancers

NCT ID: NCT05827471 Not yet recruiting - Colon Cancer Clinical Trials

Clinical Study of QSOX1 as a Biomarker for Colon Cancer

Start date: July 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to determine whether the secreted protein QSOX1 can be used as a molecular marker for early rapid diagnosis and accurate treatment of colon cancer.

NCT ID: NCT05816187 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment.

Start date: June 2023
Phase: N/A
Study type: Interventional

OBJECTIVE: To evaluate the effectiveness of a PET scan in oncological patients, with and without simultaneous treatment with chemotherapy, radiotherapy or hormonal therapy, in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention. DESIGN: Randomized controlled clinical trial, parallel groups with active control group. With randomization blinding, patient assessment and data analysis. STUDY SUBJECTS: 78 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (aromatase inhibitors, tamoxifen). INTERVENTION: three treatment groups: supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy, radiotherapy or hormonal treatment, supervised therapeutic exercise group with simultaneous chemotherapy, radiotherapy or hormonal treatment and control group. Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised. Patients will be followed for 1 year, with five blinded assessments: at baseline, after 6 weeks of intervention, 3, 6 and 12 months after baseline. MEASUREMENTS: Main: Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Measured pre-post intervention, 3, 6 and 12 months. Secondary: Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Measured pre-post intervention, 3, 6 and 12 months. Functional capacity measured with the 6-minute walk test. Pre-post intervention measurement, 3, 6 and 12 months. Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test. Pre-post intervention measurement, 3, 6 and 12 months.

NCT ID: NCT05801211 Not yet recruiting - Colon Cancer Clinical Trials

Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer

CROSCO-1
Start date: May 1, 2023
Phase:
Study type: Observational

CROSCO-1 study is a national, multi-center, prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer (in the absence of metastases and peritoneal carcinomatosis) undergoing primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure") or staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS). The main questions it aims to answer are: - the Stoma rate at 1 year after tumor resection - the 30-day and 90-day major morbidity and mortality - 1-year quality of life (EQ-5D-5L test) - Timing of chemotherapy initiation and type of chemotherapy regimen. Participants will have an obstructive left colon cancer localized (no peritoneal carcinosis or distant metastasis). Researchers will compare: primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or an "Hartmann's procedure" with a staged resection after endoscopic stenting with SEMS.

NCT ID: NCT05732493 Not yet recruiting - Clinical trials for Locally Advanced Colon Cancer

Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

TORCH-C
Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response (pCR), long-term prognosis and adverse effects will be analyzed.

NCT ID: NCT05715905 Not yet recruiting - Colon Cancer Clinical Trials

Analyzing Clinical Trial Experiences of Colon Cancer Patients

Start date: February 2024
Phase:
Study type: Observational

Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This trial will admit a wide range of data on the clinical trial experience of Colon Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Colon Cancer patients.

NCT ID: NCT05493033 Not yet recruiting - Colon Cancer Clinical Trials

Intracorporeal Versus Extracorporeal Anastomotic After Laparoscopic Right Colectomy

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Background: Laparoscopic assisted right hemicolectomy is recommended for right colon cancer. As a more minimally invasive procedure, intracorporeal ileocolic anastomosis has potential advantages: reducing torsion and traction on the mesentery, reducing skin incision length and enhancing postoperative recovery. However, the longer operative time, greater risk of intra-abdominal infection and steep learning curve for intestinal anastomosis performed under laparoscopic conditions, does this increase the incidence of postoperative complications, especially the incidence of anastomotic leakage, and whether it affects There is no high-level research evidence on the survival of patients. Study design: COlOR IV study is an international prospective, multicenter, randomized controlled clinical study of intraperitoneal anastomosis versus extraperitoneal anastomosis after laparoscopic right hemicolectomy for colon cancer . The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the intracorporeal and extracoporeal techniques. Endpoint: Primary outcome is anastomotic leakage within 30 days after surgery. Main secondary endpoint is 3-year disease-free survival rate. Secondary endpoints are mortality and morbidity, postoperative recovery, overall survival, surgical specimen quality, quality of life. Statistics: The primary endpoint is anastomotic leakage within 30 days after surgery. The anastomotic leakage rate was set to 2% in the both groups, and an increase in the incidence of anastomotic leakage of 2.5% was considered inferior. The one-sided significance level was 0.025, the power was 0.9. The dropout rate was 20%, and taking into account the post-randomization analysis (dropout 5%), the total sample size was 1158. There were 579 cases in the intracorporeal anastomosis group and 579 cases in the extracorporeal anastomosis group. Main selection: Patients with histologically proven right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon malignant tumor), clinically stage I-III, and intention for right hemicolectomy with primary anastomosis. Hypothesis: The hypothesis is that intracoporeal anastomosis will have comparable anastomotic leak rate and 3-year DFS, but faster postoperative recovery with extracoporeal anastomosis.

NCT ID: NCT05356897 Not yet recruiting - Clinical trials for Stage IV Colorectal Cancer AJCC v8

Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study

Start date: November 30, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial studies whether tucatinib combined with trastuzumab and TAS-102 works to shrink tumors in patients with HER2 positive colorectal cancer that has spread to other parts of the body (metastatic) and has one of the following gene mutations detected in blood: PIK3CA, KRAS, NRAS, or BRAF V600. Tucatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. TAS-102 is a combination of 2 drugs; trifluridine and tipiracil. Trifluridine is in a class of medications called thymidine-based nucleoside analogues. It works by stopping the growth of tumor cells. Tipiracil is in a class of medications called thymidine phosphorylase inhibitors. It works by slowing the breakdown of trifluridine by the body. Giving tucatinib, trastuzumab, and TAS-102 together may work better than usual treatment for metastatic colorectal cancer.

NCT ID: NCT05335460 Not yet recruiting - Colon Cancer Clinical Trials

To Determine the Efficacy and Safety of Envafolimab Combined With XELOX for Locally Advanced Colon Cancer

Start date: May 2022
Phase: Phase 2
Study type: Interventional

The objective is to investigate the efficacy and safety of Envafolimab combined with XELOX in neoadjuvant therapy for locally advanced colon cancer

NCT ID: NCT05334251 Not yet recruiting - Anesthesia Clinical Trials

General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?

Start date: April 2022
Phase:
Study type: Observational [Patient Registry]

Anesthesia management in colon cancer surgery affects the postoperative mobilization, discharge and oral intake times of the patients. Due to the side effects of opioids, their use is tried to be reduced and therefore regional anesthesia methods are preferred in suitable patients. Especially in the preoperative period, opioid use has a negative effect on the recovery processes, morbidity and mortality of the patients. Epidural analgesia, a central block method, is recommended for postoperative pain control in ERAS protocols. Opioids suppress cellular and humoral immunity. Epidural analgesia reduces both opioid consumption and surgical stress response. It has been shown that epidural analgesia maintains the immune functions of patients and is associated with a decrease in tumor recurrence. It has also been shown to reduce postoperative pain, hypercoagulability and pulmonary complications, increase exercise capacity and accelerate the return of intestinal functions to normal. In line with this information, in this study, it was aimed to investigate the differences in the postoperative period in patients managed with regional anesthesia. In the study, it was planned to create two groups who underwent open surgery for colon cancer. The first group will be operated under general anesthesia and the second group will be operated under combined spinal-epidural anesthesia with ketofol sedation. An epidural catheter will be inserted in both groups for postoperative pain management. In the study, patients' age, gender, weight, comorbidity, ASA score, amount of local anesthetic used, postoperative VAS scores, mobilization time, time to start oral intake, nasogastric withdrawal time, drain removal time, urinary catheter withdrawal time, hospitalization time and total cost will be evaluated.