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Rectal Neoplasms clinical trials

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NCT ID: NCT05653934 Recruiting - Pain, Postoperative Clinical Trials

Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer

VIREA
Start date: May 2023
Phase: N/A
Study type: Interventional

In patients operated for colorectal cancer, pain, anxiety and depression are important factors in postoperative rehabilitation. The use of new technologies, as virtual reality immersion, could further improve their postoperative management. To date, no study has evaluated the potential benefits of using virtual reality before and after colorectal cancer surgery. The main objective is to determine if virtual reality can reduce postoperative anxiety in patients undergoing colorectal cancer surgery. To answer this question, the investigators plan to execute a randomized controlled, single-center, open-label, superiority interventional trial. Patients will be randomized into 2 parallel arms: 1 interventional "virtual immersion" arm and 1 "control" arm. Patients with colorectal cancer, regardless of oncological stage, or a colorectal lesion deemed endoscopically unresectable, with an indication for elective surgical management by laparotomy or laparoscopy will be included. For patients in the interventional arm, virtual reality headset is put on the day before the operation and in the morning just before going down to the operating theatre. Colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. This is a purely contemplative mode, lasting maximum 30 minutes. For the control arm, patients are treated according to the usual practices of the department and do not have access to virtual reality. The main purpose is to show a greater decrease in anxiety in the interventional group by measuring the absolute difference between the State-Trait Anxiety Inventory scores before surgery and at discharge.

NCT ID: NCT05652361 Recruiting - Rectum Cancer Clinical Trials

Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery

CoBot2
Start date: May 19, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.

NCT ID: NCT05651971 Recruiting - Rectal Cancer Clinical Trials

The Anatomical Localization of the Inferior Mesenteric Artery in Relation to the Left Colonic Artery

Start date: November 1, 2022
Phase:
Study type: Observational

1. To observe and measure the distance between the origin of LCA (left colonic artery,LCA) and IMA (inferior mesenteric artery,IMA) root and the distance between IMA and IMV (inferior mesenteric vein,IMV) at the origin of LCA in rectal cancer patients. Statistical analysis of intraoperative measured data, on the basis of the original anatomical relationship, to achieve anatomical localization of quantitative and accurate, for the preservation of LCA laparoscopic radical resection of rectal cancer to provide a strong anatomical basis. 2. The operation time, 253 lymph node dissection time, intraoperative blood loss, postoperative anal exhaust time, postoperative feeding time, postoperative hospital stay, postoperative ischemic colitis rate and postoperative anastomotic leakage rate of patients with laparoscopic radical resection of rectal cancer with preservation of LCA were recorded. The surgical efficacy and clinical significance of laparoscopic radical resection of rectal cancer with preservation of LCA were evaluated.

NCT ID: NCT05646511 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Total Neoadjuvant Therapy of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer (ENSEMBLE)

ENSEMBLE
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.

NCT ID: NCT05646043 Recruiting - Cancer, Rectum Clinical Trials

PREHAB - Improving Condition Before Surgery

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).

NCT ID: NCT05645094 Not yet recruiting - Clinical trials for Locally Advanced Rectal Carcinoma

Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

Start date: January 1, 2023
Phase:
Study type: Observational

This is a single center, prospective, single arm clinical trial to evaluate the efficacy and safety of Envafolimab as a neoadjuvant therapy for resectable and locally advanced dMMR or MSI-H rectal cancer.

NCT ID: NCT05640726 Not yet recruiting - Rectal Cancer Clinical Trials

The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

NCT ID: NCT05629442 Not yet recruiting - Rectal Cancer Clinical Trials

ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer

Start date: January 2023
Phase:
Study type: Observational

This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.

NCT ID: NCT05628038 Recruiting - Clinical trials for Recurrent Rectal Cancer

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

TORCH-R
Start date: August 18, 2022
Phase: Phase 2
Study type: Interventional

The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment. Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.

NCT ID: NCT05622357 Completed - Clinical trials for Locally Advanced Rectal Carcinoma

Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

Start date: March 18, 2018
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are: - Is total neoadjuvant treatment in this design safe & tolerable? - Impact of this design on treatment related outcomes in terms of pathological and clinical responses.