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Rectal Neoplasms clinical trials

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NCT ID: NCT03896958 Recruiting - Breast Cancer Clinical Trials

The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)

PIONEER
Start date: March 21, 2019
Phase:
Study type: Observational

The PIONEER Initiative stands for Precision Insights On N-of-1 Ex vivo Effectiveness Research. The PIONEER Initiative is designed to provide access to functional precision medicine to any cancer patient with any tumor at any medical facility. Tumor tissue is saved at time of biopsy or surgery in multiple formats, including fresh and cryopreserved as a living biospecimen. SpeciCare assists with access to clinical records in order to provide information back to the patient and the patient's clinical care team. The biospecimen tumor tissue is stored in a bio-storage facility and can be shipped anywhere the patient and the clinical team require for further testing. Additionally, the cryopreservation of the biospecimen allows for decisions about testing to be made at a later date. It also facilitates participation in clinical trials. The ability to return research information from this repository back to the patient is the primary end point of the study. The secondary end point is the subjective assessment by the patient and his or her physician as to the potential benefit that this additional information provides over standard of care. Overall the goal of PIONEER is to enable best in class functional precision testing of a patient's tumor tissue to help guide optimal therapy (to date this type of analysis includes organoid drug screening approaches in addition to traditional genomic profiling).

NCT ID: NCT03895255 Recruiting - Rectal Cancer Clinical Trials

Selective sPlenic flExure Mobilization for Low colorEctal Anastomosis After D3 lYmph Node Dissection (Speedy Trial)

SpeeDy
Start date: October 2, 2016
Phase: N/A
Study type: Interventional

In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated. The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular sheath of inferior mesenteric artery (IMA) in low anterior resection of the rectum for cancer. This study purpose to demonstrate that low IMA ligation, sparing of left colic artery (LCA) and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%).

NCT ID: NCT03890926 Completed - Clinical trials for Rectum Cancer, Recurrent

The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy

Start date: December 2015
Phase:
Study type: Observational

This study observes the efficacy and side effects of 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

NCT ID: NCT03881332 Completed - Rectal Cancer Clinical Trials

Measurement of Perioperative Glomerular Filtration Rate

Start date: December 26, 2019
Phase:
Study type: Observational [Patient Registry]

Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

NCT ID: NCT03879109 Active, not recruiting - Rectal Cancer Clinical Trials

Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer

GRECCAR15
Start date: July 8, 2019
Phase: Phase 3
Study type: Interventional

GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area. The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.

NCT ID: NCT03876561 Recruiting - Rectal Cancer Clinical Trials

"Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"

CONTICARE
Start date: May 27, 2019
Phase: N/A
Study type: Interventional

There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS. The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.

NCT ID: NCT03875781 Recruiting - Rectal Cancer Clinical Trials

Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer

NORAD01
Start date: June 5, 2019
Phase: Phase 3
Study type: Interventional

This study is a non-inferiority phase III randomised trial comparing preoperative chemotherapy alone (modified FOLFIRINOX) to chemotherapy followed by chemoradiotherapy in patients with primary resectable locally advanced rectal cancer. The primary endpoint of the study is 3-year progression free survival. Expected 3 year PFS rate in the preoperative chemotherapy followed by chemoradiotherapy arm is 75%. This hazard rate, in an exponential survival model, corresponds to a decrease in the 3-year PFS rate on the preoperative chemotherapy arm to 67%. The study will randomize 540 patients (270 in the chemotherapy group and 270 in the chemoradiotherapy group) in 42 french academic centers.

NCT ID: NCT03875612 Completed - Rectal Cancer Clinical Trials

Radiographic Validation of the Inferior Mesenteric Artery Tie Level in Rectal Cancer Surgery

RAVAL
Start date: December 12, 2016
Phase:
Study type: Observational

The inferior mesenteric artery is the feeding vessel for tumours in the rectum. When performing surgery for these tumours, the surgeon can cut the vessel close to the aorta or after the vessel bifurcates to the superior rectal artery and the left colic artery. A close division is termed a high tie (and the other, a low tie) and might entail a better lymph node extraction, possibly removing metastasis, but can also lead to nerve damage and e.g. bowel dysfunction. There is no clear evidence favouring either tie level, and large amounts of data are needed to establish superiority as any effects is likely to be small. One such method is to use national registries with prospectively collected data on e.g. level of tie and cancer relapse. However, it is not always easy to determine the level of tie while in the operating room and registries might also contain erroneous data. In order to determine the validity of such data, comparisons to objective measures are needed. This study is an attempt to correlate radiographic imaging to the suggested tie level, as indicated by the surgeon in the operative report and by the nationwide Swedish Colorectal Cancer Registry. If the registry variable tie level has a high correlation with imagining, researchers can more reliably use the registry to establish the benefits and drawbacks with high tie in rectal cancer surgery.

NCT ID: NCT03874559 Recruiting - Rectal Cancer Clinical Trials

Exosomes in Rectal Cancer

Start date: February 13, 2018
Phase:
Study type: Observational [Patient Registry]

The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

NCT ID: NCT03871790 Completed - Pancreatic Cancer Clinical Trials

Peptide-based Immunization for Colon- and and Pancreas-carcinoma

PICOP-GLOBAL
Start date: April 1, 2019
Phase:
Study type: Observational

An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.