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Rectal Neoplasms clinical trials

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NCT ID: NCT00531297 Terminated - Rectal Neoplasms Clinical Trials

Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Start date: December 1, 2005
Phase: N/A
Study type: Interventional

Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or even abdominoperineal resection are linked to the risk of locoregional recurrence of about 10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly, in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or radiotherapy were developed, given the uncertainty about the lymph node stage. Another approach was to identify histological risk criteria in the primary tumor in terms of defining the limits of rectum-sparing therapy. In earlier experimental and clinical studies the investigators researched and applied dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this technique becomes all the more significant, as the perineal approach makes it possible to perform an endoscopic posterior mesorectal resection (EPMR) in combination with rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be removed and histologically examined. As a consequence EPMR should lower the loco-regional recurrence rate, since the most common causes of such are pre-existent but so far not detectable lymph node metastases besides the incomplete resection of the primary tumor.

NCT ID: NCT00515853 Completed - Fecal Incontinence Clinical Trials

The Role of Biofeedback in Improving Continence After Anterior Resection

Start date: November 27, 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

NCT ID: NCT00509444 Completed - Breast Cancer Clinical Trials

Cancer Prevention and Treatment Among African American Older Adults: Treatment Trial

CPTD
Start date: October 2006
Phase: Phase 3
Study type: Interventional

The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6 sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ, Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in cancer treatment among seniors from U.S. racial and ethnic minority populations. Each site will focus on a specific racial/ethnic minority group, and collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be administered at baseline to all participants in the demonstration. Participant identification, randomization, and intervention implementation will be standardized across sites. Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in collaboration with the Baltimore City Community Health Coalition is designed to address persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment. Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in intensity to improve continuity and outcomes of care among African Americans seniors. Among African American seniors, compared to a less intensive intervention (general information and educational materials), does the addition of facilitation services delivered by a health coordinator result in a greater improvement in adherence to recommended treatment among those diagnosed with breast, cervix, colon/rectum, prostate, or lung cancer? Study Population: We will recruit African Americans, age 65 years or older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty guideline, and 55.6% are African American.) The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer Screening Assessment (CSA). They will then be randomized to receive a less intensive or more intensive intervention. The less intensive group will receive general information about cancer and Medicare covered services and instructions to discuss the information with their primary care doctor. The more intensive group will receive the same information as the less intensive group receives, plus tailored facilitation services delivered by a nurse-supervised community health worker. The primary outcome variable for the trial will be the difference between randomized groups in adherence to treatment for breast, cervix, colon/rectum, prostate and lung cancer. A community advisory committee will guide all aspects of the study and will include important stake holders (both public and private sectors), representatives from the Baltimore City Community Health Coalition, the Baltimore City Department of Health, the Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care providers (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers, pathologists) and academicians.

NCT ID: NCT00506844 Active, not recruiting - Rectal Neoplasms Clinical Trials

Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer

ERBIRIX
Start date: May 2006
Phase: Phase 2
Study type: Interventional

This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.

NCT ID: NCT00506623 Active, not recruiting - Neoadjuvant Therapy Clinical Trials

Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer

NCT ID: NCT00504153 Completed - Clinical trials for Recurrent Rectal Cancer

Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Start date: July 2007
Phase: Phase 2
Study type: Interventional

This phase II trial is studying dasatinib to see how well it works in treating patients with previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

NCT ID: NCT00503932 Withdrawn - Rectal Cancer Clinical Trials

Proton Therapy With Capecitabine for Rectal Cancer

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I portion of this trial. The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD. Secondary Objectives: 1. To evaluate local tumor response in patients treated with the above regimen. 2. To evaluate the relapse-free and overall survival in patients treated with the above regimen. 3. To evaluate proton dosimetry in patients receiving this treatment. 4. To evaluate quality of life in patients receiving this therapy.

NCT ID: NCT00499369 Terminated - Clinical trials for Recurrent Rectal Cancer

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

Start date: June 2007
Phase: Phase 3
Study type: Interventional

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.

NCT ID: NCT00470951 Active, not recruiting - Rectal Cancer Clinical Trials

Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer

CTS-179
Start date: April 2006
Phase: Phase 3
Study type: Interventional

The investigators designed the randomized prospective trial of comparing open and laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in order to determine the oncologic and functional efficacy of laparoscopic rectal resection.

NCT ID: NCT00457327 Terminated - Rectal Cancer Clinical Trials

Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

Start date: July 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer