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Rectal Neoplasms clinical trials

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NCT ID: NCT02651701 Completed - Rectal Cancer Clinical Trials

Rectal Cancer Staging Using Whole Body MR-PET

Start date: January 2016
Phase:
Study type: Observational

The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.

NCT ID: NCT02649647 Recruiting - Rectal Cancer Clinical Trials

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

PERN
Start date: February 2016
Phase: N/A
Study type: Interventional

Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery. Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis. It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.

NCT ID: NCT02648386 Recruiting - Rectal Cancer Clinical Trials

Stem Cell Therapy Combined With NeuroRegen Scaffold™ in Patients With Erectile Dysfunction After Rectal Cancer Surgery

Start date: January 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.

NCT ID: NCT02641691 Completed - Rectal Cancer Clinical Trials

Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

NORMAL-R
Start date: May 27, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.

NCT ID: NCT02640586 Active, not recruiting - Rectal Neoplasms Clinical Trials

Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

Start date: January 10, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

NCT ID: NCT02639403 Completed - Rectal Neoplasms Clinical Trials

Palliative Short-Course Radiotherapy in Rectal Cancer

Start date: October 2003
Phase: Phase 2
Study type: Interventional

Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have been published more than two decades ago and were based on 2D conventional RT, which is nowadays no longer used. Consequently, prospective studies on the efficacy of 3D-RT in the management of symptomatic rectal cancer are still lacking. The aim of this prospective study was to assess the efficacy of palliative short-course 3D RT (SCRT) in patients with symptomatic obstructive rectal cancer.

NCT ID: NCT02630056 Not yet recruiting - Rectal Neoplasm Clinical Trials

Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer

Start date: December 2015
Phase: N/A
Study type: Observational

The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

NCT ID: NCT02626728 Completed - Rectal Cancer Clinical Trials

A Prospective Feasibility Study for TAMIS

TAMIS
Start date: September 2015
Phase: N/A
Study type: Observational

Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.

NCT ID: NCT02624115 Completed - Clinical trials for Colon Rectal Cancer Adenocarcinoma

FAZA PET as Biomarker for Hypoxia in Rectal Cancer

Start date: May 1, 2016
Phase:
Study type: Observational [Patient Registry]

Colorectal cancer (CRC) is one of the leading causes of cancer mortality in Canada. Rectal cancers are now known to be hypoxic which is a negative prognostic factor and predictive of metastatic spread and poor responsiveness to treatment. This has also been shown in preclinical xenograft models. Hence there is a need for identification of hypoxic rectal cancers. In this pilot study the investigators intend to non-invasively assess the tumor and nodal metastasis using an integrated Positron Emission Tomography-Magnetic Resonance Imaging scanner (PET/MRI) with 18F-Fluoroazomycin Arabinoside (18F-FAZA) a radiopharmaceutical for assessing tumor hypoxia. The hypoxic rectal tumors will show an increased uptake of 18F-FAZA on PET which will have morphological correlation on MRI. The patient will then undergo neoadjuvant chemoradiation therapy (CRT) followed by repeat 18F-FAZA PET/MRI and rectal cancer surgery with pimonidazole staining. Pimonidazole is an extrinsic marker of hypoxia that is selectively reduced and covalently bound to intracellular macromolecules in areas of hypoxia within normal and tumor tissue with current approval for use in humans for research studies. The primary goal of this pilot trial is to validate FAZA-PET as a biomarker of hypoxia by correlating its uptake in rectal tumors to pimonidazole staining in histopathology specimens. If the investigators pilot study successfully demonstrates the uptake and correlation of pimonidazole and FAZA-PET, the investigators would like to initiate a larger study examining hypoxia in rectal cancer. The investigators aims would be to image patients with locally advanced rectal cancer before CRT to ascertain whether high FAZA-PET uptake correlates with poor outcome to CRT. The ability to preoperatively predict the patient sub-population that will respond best to CRT, will help to identify the "complete pathological" responders and avoid unnecessary surgery. Furthermore, the FAZA-PET high subset of patients may benefit from other treatment strategies including clinical trials of anti-hypoxic agents.

NCT ID: NCT02614157 Terminated - Rectal Cancer Clinical Trials

Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer

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

Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer, not regular predictive LLND, which will bring more side effects on the contrary. Existing reports tend to recommend LLND for specific individual with suspicious LLN metastasis. Moreover, there is a blank strict prospective randomized control study on the comparison of LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.