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Rectal Neoplasms clinical trials

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NCT ID: NCT06462053 Recruiting - Clinical trials for Early Low Rectal Cancer

Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer

TORCH-E2
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response [pCR] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.

NCT ID: NCT06455124 Recruiting - Rectal Cancer Clinical Trials

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

Start date: May 8, 2024
Phase: Phase 2
Study type: Interventional

This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

NCT ID: NCT06442215 Recruiting - Rectal Neoplasms Clinical Trials

Selection of Surgical Technique in Rectal Cancer

TECARE
Start date: April 3, 2024
Phase:
Study type: Observational

Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes. Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.

NCT ID: NCT06417476 Recruiting - Rectal Neoplasms Clinical Trials

Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer

Start date: December 12, 2022
Phase: Phase 2
Study type: Interventional

Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy, it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer. This approach aims to improve disease-free survival (DFS), while minimizing or circumventing the organ dysfunction and subsequent decline in quality of life associated with radical surgery. Consequently, we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy (comprising either short-course radiotherapy or long-course chemoradiation, followed by consolidation chemotherapy with mFOLFOXIRI) in increasing organ preservation rates in patients with low rectal cancer.

NCT ID: NCT06402864 Recruiting - Clinical trials for Adult With Intermediate Low or Mid Rectal Adenocarcinoma

Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma

TRESOR
Start date: March 26, 2024
Phase: Phase 3
Study type: Interventional

Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation. Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.5 to 6 cm, cT2N1 or T3N0-1, M0).

NCT ID: NCT06380855 Recruiting - Rectal Cancer Clinical Trials

Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME)

Start date: August 24, 2022
Phase:
Study type: Observational

The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury.

NCT ID: NCT06380101 Recruiting - Rectal Cancer Clinical Trials

Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)

NEAAR-LARC
Start date: September 8, 2023
Phase: N/A
Study type: Interventional

This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.

NCT ID: NCT06364384 Recruiting - Clinical trials for Rectal Squamous Cell Carcinoma

Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma

Start date: April 12, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are: Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime? Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs. Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.

NCT ID: NCT06337552 Recruiting - Rectal Cancer Clinical Trials

High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiotherapy (CRT).

NCT ID: NCT06328361 Recruiting - Rectal Cancer Clinical Trials

Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer

NORPPA-1
Start date: May 16, 2024
Phase: N/A
Study type: Interventional

The goal of this one-arm clinical trial is to implement and study the oncological outcomes of nonoperative management of rectal cancer having complete clinical response to neoadjuvant therapy. The main questions to answer are - if the oncological results of nonoperative management after Nordic practice in chemoradiotherapy indications differ from experiences elsewhere - what is the organ preservation rate - what is the local regrowth rate