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Rectal Cancer clinical trials

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NCT ID: NCT06014944 Not yet recruiting - Rectal Cancer Clinical Trials

Short-course Radiotherapy Combined With Furoquintinib and PD-1 Monoclonal Antibody

PMMR/MSS
Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

The investigators conduct a single-arm, single-center, prospective clinical study enrolling patients diagnoses with pMMR / MSS type middle and low locally advanced rectal cancer who had not received systemic anti-tumor therapy to explore the efficacy and safety of short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody as neoadjuvant therapy.

NCT ID: NCT05969847 Not yet recruiting - Rectal Cancer Clinical Trials

Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer

TRACE-LE
Start date: August 15, 2023
Phase: Phase 2
Study type: Interventional

Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness resection was implemented.

NCT ID: NCT05965531 Not yet recruiting - Rectal Cancer Clinical Trials

Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy

TASLARC
Start date: November 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this Phase 2 trial is to evaluate a neoadjuvant treatment mode for locally advanced rectal cancer (LARC), consisting of radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). The main questions it aims to answer are: (i) whether TAS-102 is effective in treating LARC, when combined with radiotherapy; (ii) whether TAS-102 is safe in combination with radiotherapy. Participants will receive one cycle of TAS-102 chemotherapy and neoadjuvant radiotherapy based on intensity-modulated technique. Then the ones with a possibility of R0 resection will receive radical surgery followed by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.

NCT ID: NCT05938322 Not yet recruiting - Rectal Cancer Clinical Trials

Ketogenic Diet Compliance in Patients Affected by Locally Advanced Rectal Cancer Patients Who Undergo to Radiotherapy

KOMPARC
Start date: July 2023
Phase: N/A
Study type: Interventional

Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups: - the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period - the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment

NCT ID: NCT05911789 Not yet recruiting - Rectal Cancer Clinical Trials

Online Adaptive Radiation Therapy for Rectal Cancer

Start date: August 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

NCT ID: NCT05910099 Not yet recruiting - Rectal Cancer Clinical Trials

Taking a Look at Patient Experiences In Rectal Cancer Clinical Trials

Start date: July 2024
Phase:
Study type: Observational

The primary objective of this research study is to explore the barriers encountered by specific demographic groups of rectal cancer patients during the engagement in clinical trials, which historically lack diverse representation. By carefully analyzing data from various demographic perspectives, this study aims to uncover patterns that impact the experiences of future rectal cancer patients. Active involvement in this crucial research is of utmost importance, as it can offer unique insights to enhance the participation and completion rates of rectal cancer patients in clinical study.

NCT ID: NCT05807984 Not yet recruiting - Rectal Cancer Clinical Trials

Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion

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

Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)

NCT ID: NCT05807646 Not yet recruiting - Rectal Cancer Clinical Trials

Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.

Start date: January 2025
Phase: N/A
Study type: Interventional

Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS)

NCT ID: NCT05793554 Not yet recruiting - Rectal Cancer Clinical Trials

CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery Study 1

Start date: March 2023
Phase:
Study type: Observational

Cancer of the lowermost part of the intestine (the rectum) is a common disease and both this disease and its treatment can have major impact on patients. Unless treated early, the disease can progress, spread to other parts of the body and ultimately cause death. Treatment often involves radical surgery, but this too has consequences and risks major complications. Best outcomes regarding cure with least impact depend on the disease being detected at an early stage as rectal cancer tends to start first as a non-cancerous polyp. The smallest of these precursor polyps can be easily removed during a routine colonoscopy but once the polyp grows over 2cm in size it is much harder to categorise correctly as the risk of it containing cancer somewhere in it increases markedly. If there is definitely cancer present in such a polyp it is best treated from the outset as a cancer with major surgery, but if there is definitely not a cancer in it then it can be removed from inside the bowel with minimally invasive techniques. Unfortunately, despite our current very best methods, up to 20% of tumours initially thought to be benign are found to be malignant only after they are excised We have previously shown that cancerous and non-cancerous tissues can be visually differentiated by analysis of their perfusion during the examination. For this we use a specific approved fluorescent dye, indocyanine green (ICG). ICG is commonly used in bowel surgery anyway to assess the blood supply to the bowel and has a very good safety profile. ICG is injected into the bloodstream during surgery and the rate at which it is taken up by various tissue types is detected by specific and approved cameras which can reveal fluorescence in tissue. We have previously found that the rate of uptake of this dye is different in cancer tissue compared to non-cancer tissue and have used artificial intelligence algorithms to measure this difference. However, we now need to ensure that this method can work also in other patients, in other centres and indeed in other countries to ensure it is indeed a valid and useful way of assessing rectal polyps. The goal of this observational study is to validate the use of fluorescence pattern analysis in the classification of rectal tumours. Patients enrolled in the study will attend for a visual examination of the rectal tumour in theatre as is standard practice. During this examination a video recording of the fluorescence perfusion will be taken following ICG administration. Patients will then have the tumour excised or treated as is standard of care by their surgeon. The video will later be analysed to determine the pattern of fluorescence perfusion within the tumour, and a classification will be assigned based on the pattern seen. All tumours that are excised are examined under the microscope by a pathologist to determine the final diagnosis. The fluorescence based classification will be compared to this pathological diagnosis to determine the accuracy of the method. So, patients will still have the exact same standard of care as currently happens, the hope is that in future this method can be developed to the point where it could be useful by means of a useable, accurate automated software process. If so, that will form the basis of another study in the future to look to see if it can guide or even replace biopsies and help with ensuring complete removal ('clear margins') after excision.

NCT ID: NCT05671809 Not yet recruiting - Rectal Cancer Clinical Trials

Effects of Different Treatment for Anorectal Function of Patients With Rectal Cancer

ARF-RC
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

Background Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard treatments for patients with locally advanced rectal cancer. These sphincter-saving operations may be accompanied by a series of functional disorders. Prospective studies dynamically evaluating the different roles of surgery and NCRT on anorectal function are lacking. Methods/design The study is a prospective, observational, controlled, multicentre study. After screening for eligibility and obtaining informed consent, a total of 402 rectal cancer patients aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University are included in the trial. The primary outcome measure is the average resting pressure of anal sphincter. The secondary outcome measures are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years. Discussion We expect the program to provide more information on therapeutical options and strategies to reduce anorectal dysfunction of rectal cancer patients who have been undergone sphincter preservation treatments.