Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Sigmoid Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Sigmoid Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.

The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.

(1 week before surgery and 3 weeks after surgery)

The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'

Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.

The patients enrolled into placebo comparator group will take one pack of 'Placebo' which is composed of lactose and simulates a 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.

(1 week before surgery and 3 weeks after surgery)

The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'

Mechnicov probiotics

Placebo

SungSik Jang, Ph.D

The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.

The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.

This study has been designed for randomized, double Blinded, placebo clinical trial.

The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome After Anterior Resection of Colon Cancer; Double-blind, Randomized, Placebo-controlled Trial

WBC, Neutrophil, lymphocyce, monocyte, Plt count, neutrophil-lymphocyte ratio

PG-SGA: Patient-Generated Subjective Global Assessment

Assessment through "Clavien-Dindo Classification"

NGS(New Generation Sequencing), SCFA(Short-Chain Fatty Acid)

Kye Bong-Hyeon

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Erectile Dysfunction

Rectal Neoplasms

Rectal Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Udenafil

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

oral administration of placebo for Udenafil (Dong-A Pharmaceutical co., Ltd, Seoul, Korea)

oral administration of Udenafil, prn(2hours before anticipated intercourse, 8 times/months)

Sung-Bum Kang, M.D., Ph.D

The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery.

Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable during anterior rectal dissection. There may be also a contribution of psychological factors from the presence of stoma and fear of recurrent cancer. Recently, several studies reported that erectile dysfunction after rectal excision for rectal cancer was completely reversed or satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the PDE11 isozyme and not produce significant myalgia. back pain, or leg pain.

This prospective, randomized study was designed to evaluate the efficacy of Udenafil treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed to Udenafil group or placebo group.

Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer

Efficacy of Udenafil in Treatment of Erectile Dysfunction After Radical Resection for Sigmoid Colon and Rectal Cancer : a Randomized Controlled Trial

Seoul National University Hospital

Professor

Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels.

One capsule QD oral administration for 28 days

GB104(Level 1)

Three capsules QD oral administration for 28 days

GB104(Level 2)

Five capsules QD oral administration for 28 days

GB104(Level 3)

Sujin Kim, Ph.D.

Woo Yong Lee, M.D., Ph.D.

Dae Hee Pyo, M.D., Ph.D.

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial

This is a single center, open-label, phase 1 study to evaluate the safety and tolerability of GB104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. GB104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. The dosing regimen for the study involves the oral administration of the experimental drug once a day.

Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer

Open-label, Single-center, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety and Tolerability of GB104, and Explore Gut Microbial Composition in Patients Who Completed Curative Colectomy and Planned Therapy of Colorectal Cancer

analyzed by 16S rRNA gene amplicon sequencing

* Immune response activation factors(cytokine)
* Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry

analyzed by EQ-5D-5L(EuroQoL 5-Dimensions 5-Level) questionnaire

GI Biome, Inc.

Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.

Image-guided adjuvant radiotherapy to the sigmoid colon surgical tumor bed and pelvic regional lymph nodes: 45-50.4 Gy in 1.8 Gy/fraction

Adjuvant image-guided radiotherapy

Mu-Hung Tsai, MD

Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the risk of recurrence. The radiotherapy plan must account for organ movement inside the body to ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid colon between different fractions of radiotherapy treatment (interfraction motion) and within the same fraction (intrafraction motion). This knowledge will help us determine the optimal margin to use in radiotherapy treatment planning.

Day-to-day positioning variations contribute to uncertainty in radiotherapy. The International Commission on Radiation Units and Measurements (ICRU) report 62 recommended a margin added to the clinical target volume (CTV) to produce the planning target volume (PTV). In ICRU report 83, this concept is further extended and refined to yield the internal target volume (ITV), which is defined as CTV plus a margin to account for uncertainty within the patient. Image-guided radiotherapy (IGRT) has been developed as a method to lower the margin required in PTV expansion. In current practice, IGRT methods mostly rely on bony anatomy alignment. Due to its nature, internal organ motion cannot be compensated by IGRT. Therefore, an ITV expansion is still required. The optimal ITV expansion margin depends on the magnitude of internal organ motion; the smallest margin that provides adequate coverage is preferred.

In this study, we aim to quantify organ motion of the sigmoid colon anastomosis site during radiotherapy treatment, including movement between fractions (interfraction) and movement within the same fraction (intrafraction).

Sigmoid Colon Organ Motion in Radiotherapy

Interfraction and Intrafraction Organ Motion of the Sigmoid Colon in Patients With Colorectal Cancer Undergoing Adjuvant Radiotherapy

Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT

Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) between pre-treatment cone beam computed tomography (CBCT) and post-treatment CBCT

Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome	NCT03531606	Sigmoid Colon C...	Mechnicov probi... Placebo	20 Years - 75 Years	The Catholic University of Korea
Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer	NCT00607282	Erectile Dysfun... Sigmoid Colon C... Rectal Cancer	Udenafil	19 Years - 70 Years	Seoul National University Hospital
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer	NCT05943041	Solid Tumor Colorectal Canc... Sigmoid Colon C... Rectosigmoid Ju... Cancer Rectal Cancer	GB104(Level 1) GB104(Level 2) GB104(Level 3)	19 Years -	GI Biome, Inc.
Sigmoid Colon Organ Motion in Radiotherapy	NCT03259828	Sigmoid Cancer Sigmoid Colon C...	Adjuvant image-...	20 Years -	National Cheng-Kung University Hospital

Spots Global Cancer Trial Database for sigmoid colon cancer