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Rectal Cancer clinical trials

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NCT ID: NCT01560377 Completed - Rectal Cancer Clinical Trials

Perfusion Assessment in Laparoscopic Left Anterior Resection

PILLAR II
Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.

NCT ID: NCT01554969 Completed - Rectal Cancer Clinical Trials

Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out what effects, good and/or bad, the combination of the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine, radiation, and the study drug kill cancer cells in different ways. Giving these treatments together may make your cancer shrink or slow down its growth more than it would if you got treated with capecitabine and radiation alone. This is a Phase I drug study of ganetespib given together with capecitabine and radiation in patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not approved by the Food and Drug Administration (FDA). The other two, capecitabine and radiation, are approved by FDA for use in rectal cancer. In this study, the investigators will test different dosages of the "investigational" (experimental) drug, called ganetespib (the study drug). The study drug is "investigational" because it is not approved by the FDA for use. The study drug has been previously tested in humans. The study uses a well-established process of slowly increasing drug dosage to determine the highest dosage that can be given without causing serious side effects. In addition, the study will help researchers to determine what the side effects and drug interactions might be. The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and capecitabine with radiation work in your body (for example how long the drugs last in your body.)

NCT ID: NCT01525056 Completed - Rectal Cancer Clinical Trials

Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Nodes Using Pet-Ct, CT-Perfusion and 3T MRI

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the accuracy of Positron emission tomography, Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging studies will be compared to standard imaging studies and the histopathology of the surgical specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases pretreatment better than standard pretreatment scans and will better determine the degree of response of the primary rectal tumor to preoperative chemoradiation.

NCT ID: NCT01511653 Completed - Rectal Cancer Clinical Trials

Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

GLNE010
Start date: October 2011
Phase:
Study type: Observational

The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.

NCT ID: NCT01507103 Completed - Rectal Cancer Clinical Trials

Tecemotide (L-BLP25) in Rectal Cancer

SPRINT
Start date: February 2012
Phase: Phase 2
Study type: Interventional

The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy. Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs).

NCT ID: NCT01500993 Completed - Rectal Cancer Clinical Trials

Capecitabine in the Perioperative Treatment of Rectal Cancer

Rektum-III
Start date: March 2002
Phase: Phase 3
Study type: Interventional

This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer.

NCT ID: NCT01488045 Completed - Rectal Cancer Clinical Trials

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Start date: June 2011
Phase: N/A
Study type: Interventional

The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.

NCT ID: NCT01481545 Completed - Rectal Cancer Clinical Trials

Bevacizumab With Pelvic Radiotherapy And Primary Chemotherapy in Patients With Poor-Risk Rectal Cancer

BRANCH
Start date: December 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the use of chemotherapy, radiation therapy and bevacizumab before surgery in patients with locally advanced rectal cancer (LARC).

NCT ID: NCT01460641 Completed - Rectal Cancer Clinical Trials

Perfusion CT as a Predictor of Treatment Response in Patients With Rectal Cancer

Start date: November 2011
Phase:
Study type: Observational

A research study of rectal cancer perfusion (how blood flows to the rectum over time). We hope to learn whether perfusion characteristics of rectal masses may be predictive of response to treatment and whether rectal perfusion characteristics can be used to follow response to treatment.

NCT ID: NCT01458509 Completed - Rectal Cancer Clinical Trials

Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

Start date: October 11, 2011
Phase:
Study type: Observational

It can be difficult to obtain the perspective of patients who have had bowel surgery. This study is being done because the investigators are trying to find out whether patient-reported outcomes, (results reported to investigators by the patient), on a regular basis, will help the investigators provide better patient care and symptom management. Therefore, the purpose of this study is to determine if it is possible and if it is useful to their medical care for patients who have had bowel surgery to complete surveys about their symptoms on a regular basis. In this study the surveys are completed from home, by web or by telephone, every month for 6 months. The results of this study will guide the design of large research studies on cancer-related bowel function. The purpose of this study is to develop a bowel function questionnaire for patients with colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel function.