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Rectal Neoplasms clinical trials

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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: NCT02576184 Completed - Clinical trials for Incisional Hernia After Diverting Stoma Closure

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

MEMBO
Start date: December 2015
Phase: N/A
Study type: Interventional

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

NCT ID: NCT02572362 Completed - Clinical trials for Neoplasms, Second Primary

Secondary Cancer Risk After Radiation Therapy for Rectal Cancer

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

Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having had radiation therapy for rectal cancer. Twenty-five patients are included in this study. Planning CT scans are used for comparison of dose distribution and calculation of second cancer risk.

NCT ID: NCT02569645 Completed - Rectal Cancer Clinical Trials

Rosuvastatin in the Treatment of Rectal Cancer

Start date: November 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate whether the addition of Rosuvastatin to standard chemoradiation therapy for the treatment of locally advanced rectal cancer may improve the pathological response rate and survival compared to standard chemoradiation therapy alone.

NCT ID: NCT02551471 Completed - Rectal Cancer Clinical Trials

Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer

PELVICARE
Start date: May 1, 2015
Phase:
Study type: Observational [Patient Registry]

The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15% are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The invasion of the resection margins triples the risk of local recurrence. In the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. The care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. With regards to the organization of its healthcare system, Australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.

NCT ID: NCT02551237 Completed - Rectal Carcinoma Clinical Trials

Neoadjuvant Treatment for Advanced Rectal Carcinoma

NACRE
Start date: January 7, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

NCT ID: NCT02550769 Completed - Rectal Cancer Clinical Trials

Study of NOTES-TME Versus L-LAR in Rectal Cancer

NOTESvsL-LAR
Start date: April 2015
Phase: N/A
Study type: Interventional

INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach. MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results. METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.

NCT ID: NCT02537340 Completed - Rectal Neoplasms Clinical Trials

PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR

Start date: September 2016
Phase:
Study type: Observational

The hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall survival.

NCT ID: NCT02534389 Completed - Rectal Neoplasms Clinical Trials

Fish Oil Supplement in Rectal Cancer

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

Neoadjuvant treatment with radiotherapy (RDT) and chemotherapy (CT) are the treatment of choice for rectal adenocarcinomas in stages II and III. This results currently in pathologic complete response in 10% to 30% of cases. The immune and inflammatory response is altered in these individuals and is directly related to response to therapy. Both the disease and the treatment of colorectal cancer have an impact on quality of life and nutritional status. In studies with cells and animal models the incorporation of fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) - derived from fish oil - has been shown to interfere in the process of inflammation, cell signaling and gene transcription enhancing the response to treatment. Are reported ability to restore the apoptosis of tumor cells, sensitization of tumor cells to chemotherapy, production of less pro-inflammatory cytokines and the preservation of normal energy and protein metabolism. The aim of this study is to verify if the daily consumption of 2.4 g EPA + DHA for adults in neoadjuvant therapy can promote changes on inflammatory and immunological markers of host response to tumor and if this response is altered by nutritional status. It is expected that supplementation can reflect in control of inflammatory and immune response in favor of tumor cell death contributes to pathological complete response and that it happens with preservation of nutritional status. Subjects will be randomized as to supplementation. All will be assessed in four moments during neoadjuvant therapy and immediate postoperative. Results will be presented by comparing the intervention group and control group at each moment.