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Rectal Cancer clinical trials

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NCT ID: NCT02586610 Withdrawn - Rectal Cancer Clinical Trials

Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a phase II, prospective open label multi-center study in which subjects with stage II-III rectal cancer will be accrued in order to determine the pathological complete response rate of neoadjuvant pembrolizumab in combination with chemoradiation treatment (CRT). Subjects must have a diagnosis of rectal cancer, stage II (T3-4, N0) or stage III (any T, N1-2). Subjects must have received no prior treatments (chemotherapy, pelvic radiation or surgery) for their rectal cancer. Eligible subjects will receive standard chemoradiation with pembrolizumab administered every 3 weeks on days 1, 22, and 43 of the neoadjuvant interval. In all subjects, restaging endorectal or pelvic MRI with chest and abdominal CT will be performed at 6-8 weeks after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery within 2-4 weeks of imaging; 8-12 weeks after completion of chemoradiation. Subjects who are found to have unresectable or metastatic disease post treatment with the combination of CRT+ pembrolizumab should receive standard of care definitive treatment per the discretion of their treating physician.

NCT ID: NCT02112240 Withdrawn - Rectal Cancer Clinical Trials

Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection. Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity. Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection. If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.

NCT ID: NCT01919541 Withdrawn - Rectal Cancer Clinical Trials

Mechanistic Prehabilitation

Start date: December 2016
Phase: N/A
Study type: Interventional

The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.

NCT ID: NCT01659424 Withdrawn - Rectal Cancer Clinical Trials

Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy and FOLFOX Chemotherapy for Rectal Cancer

HDRBT
Start date: June 2011
Phase: Phase 2
Study type: Interventional

Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy given with chemotherapy at the same time. External beam radiation can increase side effects both short and long-term by exposing normal tissue nearby the tumor such as the bladder, bowel and sexual organs. Instead, this study will use a different way of delivering radiation called brachytherapy to decrease normal tissue radiation exposure. Patient will be given three chemotherapy medications both before and after surgery: oxaliplatin (also called EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic Acid). The purpose of this study is to find out whether giving chemotherapy and brachytherapy before surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of tumor recurrence 3) avoid patient having the side effects related to chemotherapy and external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.

NCT ID: NCT01097239 Withdrawn - Ovarian Cancer Clinical Trials

Examining the Role of Transrectal High Intensity Focused Ultrasound (HIFU) in Rectal Pelvic Cancer

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single centre pilot trial to establish the feasibility and role of endoluminal HIFU in patients with locally advanced cancer within the pelvis that is either primary or recurrent and with all available current therapy inappropriate and/or exhausted. The aim is to make a preliminary assessment of efficacy & dosage for evaluation in a randomised controlled trial. Whilst efficacy data are limited in a small feasibility study; radiological, biochemical and histopathological analysis of the patient and patient specimens, along with quality of life questionnaires (QoL), will be used to provide preliminary measures of efficacy in this patient cohort. These analyses will allow examination of the biochemical, metabolomic and histological changes associated with HIFU treatment in cancer within the pelvis.

NCT ID: NCT00835055 Withdrawn - Rectal Cancer Clinical Trials

Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer

Start date: April 2005
Phase:
Study type: Observational

The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.

NCT ID: NCT00651677 Withdrawn - Rectal Cancer Clinical Trials

Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer

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

We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic techniques to treating patients with rectal cancer. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients.

NCT ID: NCT00575640 Withdrawn - Rectal Cancer Clinical Trials

Hydralazine as a Demethylating Agent in Rectal Cancer

Start date: November 2004
Phase: Phase 1/Phase 2
Study type: Interventional

Clinically feasible dose of Hydralazine for ~ 3 months, by virtue of its demethylating effect, will: 1. Result in re-expression of epigenetically silenced TSGs in rectal cancer specimens. 2. Decrease the global methylation in primary cancer cells compared to pre-treatment

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: NCT00346099 Withdrawn - Rectal Cancer Clinical Trials

Study of Panitumumab Given First With Capecitabine and Oxaliplatin (CAPOX) and Then With Capecitabine and Radiation of the Pelvis for Treatment of Patients With Rectal Cancers That May or May Not Have Spread Beyond the Rectum

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

Panitumumab is a monoclonal antibody. It works by attaching to a protein called epidermal growth factor receptor found on normal and cancer cells. When panitumumab attaches, it blocks another protein called epidermal growth factor (EGF) from attaching to the cell. This is important because, when EGF is blocked, a cell's growth slows down or stops. Panitumumab may also help radiation therapy work. Also because panitumumab is a fully-human antibody, it may be less toxic than other monoclonal antibodies made to block the EGF receptor. Chemotherapy, such as capecitabine and oxaliplatin, works to kill cancer cells directly. Capecitabine given during radiation helps radiation therapy work better. This study is being done to learn how rectal cancer tumors that are not removed surgically respond to treatment with panitumumab and chemotherapy given before radiation therapy begins followed by treatment with panitumumab and capecitabine given with radiation therapy.