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Rectal Cancer clinical trials

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NCT ID: NCT02437656 Completed - Rectal Cancer Clinical Trials

Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer (METCAP).

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

Metformin is an oral antidiabetic of the biguanide class derived from galega officinalis. Historical cohort of patients with diabetes have shown that diabetics on Metformin had a better chance of survival than diabetics not on Metformin. These observations have led to in vitro studies of metformin on cancer cells. It was thus demonstrated that Metformin has anti-proliferative properties. The aim of our study is to evaluate the efficacy of metformin in combination with neoadjuvant radiochemotherapy in the treatment of locally advanced rectal cancer.

NCT ID: NCT02435758 Completed - Rectal Cancer Clinical Trials

Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

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

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME). In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a multicenter randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.

NCT ID: NCT02431676 Completed - Breast Cancer Clinical Trials

Survivorship Promotion In Reducing IGF-1 Trial

SPIRIT
Start date: May 2015
Phase: Phase 2
Study type: Interventional

This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors

NCT ID: NCT02399813 Completed - Rectal Cancer Clinical Trials

A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal

Start date: June 2, 2016
Phase: Phase 2
Study type: Interventional

This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease.

NCT ID: NCT02353858 Completed - Rectal Cancer Clinical Trials

Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

HT01
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.

NCT ID: NCT02340949 Completed - Rectal Cancer Clinical Trials

Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer

RIA
Start date: January 2015
Phase: Phase 2
Study type: Interventional

This trial compares induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of pathologic complete response (pCR).

NCT ID: NCT02312284 Completed - Surgery Clinical Trials

Observational Study on the Patients With Rectal Cancer

Start date: January 2011
Phase: N/A
Study type: Observational

The aim of this observational study is to retrospectively collect current survival data for 3995 primary rectal cancer patients who were extracted from 5097 rectal cancer patients admitted in Cancer Hospital, Chinese Academy of Medical Sciences from January 2000 to December 2010. Moreover, based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients with rectal cancer treated with pre- or postoperative chemoradiotherapy (CRT).

NCT ID: NCT02243267 Completed - Rectal Cancer Clinical Trials

GI SPORE Colon Biosample Protocol

Start date: September 2014
Phase: N/A
Study type: Observational

The investigators are creating a data and specimen repository to study causes , early detection, prevention and treatment of colon and rectal cancer. The investigators are collecting data and specimens (blood, stool, urine and tissue) from people who have colon or rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies. Data and samples are held in the repository until there are enough to be used for a large study or until there are new techniques that can be used to test them. The GI SPORE Program at the University of Michigan maintains a repository of specimens for colorectal diseases that the investigators hope will help fuel new research. The investigators hope that this work may lead to new treatments or earlier detection of colorectal cancer or improved diagnosis and treatment of other colon and rectal diseases.

NCT ID: NCT02236884 Completed - Surgery Clinical Trials

The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer

Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

During the past three years, a revolutionized radical surgical approach for rectal cancer ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the conventional approach) has emerged and it is a concept that combines natural orifice transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative intent. The feasibility, safety and reproducibility of it were first demonstrated in swine survival experiments and subsequently in human cadaver series, and then it was successfully applied to human patients in few centers around the world, most of which were performed with assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases were more limited. In the initial stage, our group has successfully performed this no-scar transanal TME in a series of human cadavers with satisfactory outcome. Hence the investigators conduct this study, looking to see if this pure transanal NOTES investigational procedure is a safe and effective approach to radically remove rectal cancer of the mid and lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function and life quality when gaining the best cosmetic effect.

NCT ID: NCT02217020 Completed - Rectal Cancer Clinical Trials

Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer

FORTUNE
Start date: August 15, 2014
Phase: Phase 2
Study type: Interventional

The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.