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Colorectal Neoplasms clinical trials

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NCT ID: NCT02502656 Recruiting - Colorectal Cancer Clinical Trials

RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer

RASANC
Start date: July 2015
Phase: N/A
Study type: Observational

This study will evaluate the concordance of RAS mutation detection between the results obtained from circulating tumor DNA and those obtained with the "standard" method (testing from tumor tissue).

NCT ID: NCT02495532 Recruiting - Clinical trials for Colorectal Neoplasms

Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer

Start date: March 2015
Phase: N/A
Study type: Interventional

Regional lymph node metastasis is a major determinant of local recurrence and overall survival rates in patients with colorectal cancer. Because of the poor prognosis associated with the presence of lymph node metastasis, stage III colorectal cancer patients should receive adjuvant treatment with chemo and / or radiation therapy according to the site of tumor. Several authors have investigated the use of revealing solutions for lymph node clearance in colorectal cancer. Most studies comparing conventional histopathological specimen examination to any lymph node clearing technique showed that the use of revealing solutions increases the mean number of lymph nodes harvested, usually in a statistically significant manner. It is still controversial the impact of the use of revealing solutions for upstaging of lymph node status and consequently for the indication for adjuvant therapy. Therefore will be conducted a randomized clinical trial to compares the performance of GEWF and Carnoy solutions for the histopathological examination of patients with colorectal cancer. The aim of this study is to determine the lymph node revealing solution with the best performance (increase in the mean number of lymph node harvested and lymph node upstaging) in patients with colorectal cancer.

NCT ID: NCT02484404 Recruiting - Breast Neoplasms Clinical Trials

Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...

Start date: June 29, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer. Objectives: - Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer. Eligibility: - Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies. - Phase 2 part of the study requests the participants to have tumor samples removed. - Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression. - Participants will take olaparib or cediranib by mouth every day. - Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures. - Patients will keep a drug and diarrhea diary. - Patients on cediranib will monitor their blood pressure and keep a blood pressure diary. - Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control. - After 12 cycles, participants will have 1-3 months of follow-up.

NCT ID: NCT02476045 Recruiting - Clinical trials for Metastatic Colorectal Cancer

Panitumumab-based Maintenance in Patients With RAS Wild-type, Metastatic Colorectal Cancer (Valentino)

Valentino
Start date: June 2015
Phase: Phase 2
Study type: Interventional

Open label, randomized, multicenter, phase II study to compare the efficacy, in terms of non-inferiority of progression-free survival (PFS), of maintenance with panitumumab alone (arm B) as compared to panitumumab with 5-fluorouracil (5-FU) and leucovorin (LV) (arm A) following induction treatment with 5-fluorouracil + leucovorin+oxaliplatin (FOLFOX-4) and panitumumab in patients with RAS wild-type, metastatic colorectal cancer. The study involves an induction phase with panitumumab as 1 hour intravenous infusion at the dosage of 6 mg/kg, given every two weeks, plus FOLFOX-4 chemotherapy as standard guidelines. Before start of FOLFOX-4 plus panitumumab, at the time of enrollment, patients will be immediately randomized electronically 1:1 to one of the two maintenance arms. Induction treatment with FOLFOX-4 plus panitumumab will continue until progressive disease, unacceptable toxicity or informed consent withdrawal, or for up to 8 cycles. At the end of induction treatment, in presence of complete or partial response, or stable disease, non-progressing patients will be allocated to one of the two pre-assigned maintenance arms: A) 5-FU/LV (De Gramont regimen) plus panitumumab given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal B) Panitumumab alone given at 6 mg/Kg every two weeks until progressive disease, unacceptable toxicity or informed consent withdrawal Imaging studies (thorax and abdominal CT or MRI scan) will be performed at baseline (4 weeks prior enrollment) and every 8 weeks (4 cycles) during treatment.

NCT ID: NCT02453464 Recruiting - Clinical trials for Metastatic Colorectal Cancer

A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer

Start date: August 2015
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with FOLFIRI in patients with previously treated metastatic colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD) of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).

NCT ID: NCT02450656 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

M14AFS
Start date: June 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.

NCT ID: NCT02433626 Recruiting - Colorectal Cancer Clinical Trials

Study of COTI-2 as Monotherapy or Combination Therapy for the Treatment of Malignancies

COTI2-101
Start date: December 2015
Phase: Phase 1
Study type: Interventional

Activity of COTI-2 has been demonstrated in various cancer tumor models. With its p53- and AKT-based mechanisms of action, COTI-2 is anticipated to be highly relevant in treatment of patients with gynecologic malignancies or head and neck squamous cell carcinoma (HNSCC) as well as a variety of other tumor types. This study is designed primarily to assess the safety and tolerability of COTI-2 monotherapy or combination therapy in patients with advanced and recurrent malignancies to establish a recommended Phase 2 dose (RP2D) for future studies. Patients are currently being recruited for Part 3 of the study. Critical Outcome Technologies Inc. has been renamed to Cotinga Pharmaceuticals.

NCT ID: NCT02425657 Recruiting - Colorectal Cancer Clinical Trials

Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments

Start date: September 14, 2016
Phase:
Study type: Observational

Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al. The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .

NCT ID: NCT02376452 Recruiting - Clinical trials for Colorectal Carcinoma

Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

Start date: September 2014
Phase: Phase 2
Study type: Interventional

This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.

NCT ID: NCT02363049 Recruiting - Clinical trials for Colon Cancer Liver Metastasis

Colectomy in Patients With Asymptomatic and Unresectable Stage IV Colon Cancer

CLIMAT
Start date: July 2014
Phase: Phase 3
Study type: Interventional

The present study is a multicentric randomized phase III trial designed to assess whether overall survival and quality of life are improved in patients with asymptomatic colon cancer and unresectable SLM treated with resection of the PT followed by chemotherapy versus chemotherapy alone.