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Rectal Neoplasms clinical trials

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NCT ID: NCT05706779 Recruiting - Colorectal Cancer Clinical Trials

Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer

NEORAF
Start date: February 13, 2023
Phase: Phase 2
Study type: Interventional

This is a pilot trial which aims to assess the concept of anti-BRAF neoadjuvant treatment (encorafenib) in combination with cetuximab in patients with colon cancer or rT3/T4 supra-peritoneal upper rectal cancer based on a pre-operative CT-scan. About 10% of patients will have a mutated BRAF V600E tumour and the objective is to include 30 patients with this mutation. If the tumour is not confirmed as a carrier of the BRAF V600E mutation or has an RAS mutation according to centralised assessment, treatment will be discontinued in this patient and cancer surgery will be organised as soon as possible. The patient will be excluded from the statistical analysis and will be replaced by a new patient in order to obtain 30 patients with confirmed BRAF V600E mutation and RAS wild type . It should be noted that less than a 3% discrepancy between the numbers of local laboratory results and central analysis results, has been reported in over 600 BRAF V600E mutated colon cancers in the BEACON CRC study. Based on these figures, there should be 0 or 1 patient with discrepant results in the study presented here. Furthermore, in the hypothetical case of a patient who is an early permanent discontinuation of the study prior to surgery, this patient will be replaced in order to obtain a total of 30 patients who underwent surgery after neoadjuvant treatment.

NCT ID: NCT05696002 Recruiting - Rectal Cancer Clinical Trials

Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

Start date: January 14, 2023
Phase:
Study type: Observational [Patient Registry]

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary. Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

NCT ID: NCT05689775 Recruiting - Clinical trials for Postoperative Complications

Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

Non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. Operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.

NCT ID: NCT05684432 Recruiting - Clinical trials for Radiation-induced Diarrhoea in Prostate and Rectal Cancer

Radiation-induced Diarrhoea During Curative EBRT of Prostate and Rectal Cancer

PRECANU
Start date: June 1, 2022
Phase:
Study type: Observational

Approx. 80% of patients with prostate and rectal cancer who receive radiation therapy (RT) experience acute radiation-induced diarrhea (RID). RID has major impact on patients' quality of life, can lead to pause or early termination of RT and chronic diarrhea. RID is poorly described with few details of type and severity of RID in clinical practice and in the literature. We are conducting an observational study in patients in patients who receive curative EBRT radiation for prostate and rectal cancer to uncover the frequency and classifications of RID.

NCT ID: NCT05674422 Recruiting - Clinical trials for Patients With Locally Advanced Rectal Cancer

GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.

REVEAL
Start date: May 26, 2023
Phase:
Study type: Observational

The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional outcomes and quality of life after total mesorectal excision (TME) and especially after " Watch And Wait" (WW) is scarce. REVEAL is a prospective, multicenter study in which the response to TNT in correlation with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is planned to include 120 patients. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization. The objective of the present study is to evaluate the role of ctDNA in the prediction of relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT followed by WW or TME based on a clinical assessment of the local response

NCT ID: NCT05673772 Recruiting - Rectal Cancer Clinical Trials

Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

SOLAR
Start date: October 23, 2020
Phase: Phase 2
Study type: Interventional

The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.

NCT ID: NCT05672524 Recruiting - Rectal Cancer Clinical Trials

A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

Start date: December 30, 2022
Phase: Phase 2
Study type: Interventional

The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.

NCT ID: NCT05667181 Recruiting - Rectal Cancer Clinical Trials

The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer

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

Anastomotic complications are serious complications after anus preserving surgery for rectal cancer,the instrument anastomosis technology are one of the factors that influence the occurrence of anastomotic complications after surgery,the laparoscopic linear cutting closure device used in robotic rectal cancer may increase the occurrence of anastomotic complications,but the robot linear cutting stapler (SureForm) may reduce the incidence of postoperative anastomotic complications due to the technical advantages,therefore,the aim of this study is to evaluate the impact of robotic linear cutting stapler SureForm and laparoscopic linear cutting stapler on the incidence of anastomotic complications after robotic rectal cancer anus preserving surgery.

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.