Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Rectal CancerTME (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.
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal...
Rectal CancerThe objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.
Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma
Locally Advanced Malignant NeoplasmRectal CarcinomaThe purpose of this study is to determine whether the tailored management of locally advanced rectal carcinoma can improve the oncologic and functional outcome.
Rectal Study: Value of Repeated FDG-PET-CT Scans in Rectal Cancer
Rectum CancerTo investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy. The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response.
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical...
Medium and Lower Rectal CancerHypothesis: In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon cancer, technical management remains challenging with unresolved operating difficulties. Morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations. Reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate of fistula that results is reported in the literature between 15 and 25%. An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and mortality are reduced, and patient's quality of life greatly improved. Direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced. This study is a multicentre, two arms, phase 2 clinical trial.
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Rectal CancerLocally Advanced Rectal Cancer4 moreThe 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.
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable...
Rectal CancerThis study includes patients affected by advanced and resectable rectal adenocarcinoma. It provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free survival at two years. Translational analyses will be performed to show the presence of VEGF polymorphism, CD133 surface markers on colorectal CSCs.
Validation of ICG to Identify the Urethra During Rectal Surgery
Urethra InjuryRectal Cancer1 moreThis is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.
Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed...
Liver MetastasesMucinous Adenocarcinoma of the Colon7 moreThis phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor cells in patients with colorectal cancer and liver metastases that can be removed by surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
The Stoma Closure Before or After Adjuvant Therapy Trial
IleostomyRectal CancerThis is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a curative resection for rectal cancer and temporary ileostomy, 270 patients with indication to adjuvant chemotherapy will be randomized to early (before starting adjuvant treatment) or late (after adjuvant treatment completion) stoma closure. Primary end point will the compliance to adjuvant therapy. Secondary endpoint will include quality of life and bowel function evaluation, postoperative morbidity, chemotherapy toxicity, oncological outcomes and costs comparison.