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Colorectal Neoplasms clinical trials

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NCT ID: NCT02777710 Completed - Colorectal Cancer Clinical Trials

Evaluation of Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With CSF-1R TKI (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers

MEDIPLEX
Start date: June 2016
Phase: Phase 1
Study type: Interventional

Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have limited efficacy as single agents in both of these tumor types. Recent preclinical studies point towards alternatively activated (M2-type) macrophages as possible culprits in inducing local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents. We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose escalation study in order to evaluate the safety and clinical activity of a combined treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical activity of the combination at the RP2D.

NCT ID: NCT02776683 Completed - Clinical trials for Colorectal Neoplasms

Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer

INVICTAN®-3
Start date: June 8, 2016
Phase: Phase 3
Study type: Interventional

The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response [CR] plus partial response [PR]), overall survival (OS), duration of response (DOR), time to progression (TTP).

NCT ID: NCT02754856 Completed - Clinical trials for Stage IV Colorectal Cancer AJCC v7

Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery

Start date: July 28, 2016
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT02754661 Completed - Clinical trials for Colorectal Cancer Screening

Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.

TOPAZ
Start date: September 2016
Phase: N/A
Study type: Interventional

The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population.

NCT ID: NCT02753127 Completed - Colorectal Cancer Clinical Trials

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

CanStem303C
Start date: June 2016
Phase: Phase 3
Study type: Interventional

This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

NCT ID: NCT02751177 Completed - Clinical trials for Colorectal Cancer Metastatic

Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

ColoBEAM
Start date: March 25, 2016
Phase: N/A
Study type: Interventional

RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAMâ„¢ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

NCT ID: NCT02748811 Completed - Clinical trials for Colorectal Neoplasms

Effect of Geriatric Intervention in Frail Elderly Patients Receiving Chemotherapy for Colorectal Cancer

GERICO
Start date: May 2015
Phase: N/A
Study type: Interventional

GERICO is a randomized, controlled prospective trial. The aim is to investigate if frail, elderly patients with stage II-IV colorectal cancer, will profit from full comprehensive geriatric assessment and intervention before and during treatment with chemotherapy. The hypotheses are: Optimizing the health conditions and functional status of frail elderly patients who suffers from stage II-IV colorectal cancer, with geriatric intervention will lead to a higher grade of completing the planned chemotherapy and at higher dose intensity. This will also result in a higher overall survival and improve quality of life.

NCT ID: NCT02747862 Completed - Clinical trials for Attenuated Familial Adenomatous Polyposis

Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program

Start date: February 2008
Phase:
Study type: Observational

The primary objective of this chart review study is to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical resection of the colon. A secondary objective of this study is to compare 1) the colonoscopic and pathology histories including history of ampullary adenoma in the duodenum over family generations, 2) the use of chemopreventive medications, and 3) clinical features of subjects who pursued prophylactic surgical resection of the colon with those that have elected to continue routine colonoscopic surveillance in an effort to better characterize factors (e.g. polyp burden, ampullary adenoma and level of dysplasia, etc) which may influence management decisions.

NCT ID: NCT02746224 Completed - Colorectal Cancer Clinical Trials

Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Rectum Low Anterior Resection

TAHR
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

This is an interventional, controlled and randomized single-center clinical trial with patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer. All patients included in the study (study 1) are randomized into two groups (group 1A and group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV) and in the group 1B the surgical technique initially dissects the inferior mesenteric artery. The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis. Study hypothesis: Study 1: the surgical technique that initially dissects the IMV presents a greater number of total resected lymph nodes compared to the technique that initially dissects the IMA. Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome than termino-terminal anorectal anastomosis. Primary outcome measures: - Study 1:To compare the total number of resected lymph nodes and the distance to the surgical margins between the two arms (1A and 1B). - Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B). The anorectal function will be assessed by the scores of the validated Colorectal Functional Outcome Questionnaire (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum). Secondary outcome measures: - Study 1: to compare the duration of surgery, bleeding and need for surgical conversion between the two arms (1A and 1B). Another objectives are to compare the incidence of postoperative complications (measured by the Clavien-Dindo classification) and survival. - Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B). The anorectal function will be assessed by the validated COREFO questionnaire and the LARS scale. The quality of life will be assessed by the validated questionnaire of quality of life: SF-36. Another objective is to compare the incidence of postoperative complications assessed by the Clavien-Dindo classification and the incidence of anastomotic leakage.

NCT ID: NCT02745769 Completed - Colorectal Cancer Clinical Trials

A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents

Start date: October 21, 2016
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety of ramucirumab in combination with other targeted agents in participants with advanced cancers.