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Folate

Vitamin B9

6 cycles chemotherapy with Oxaliplatin 85 mg/m\^2 and Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 and 5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusion q2w followed by surgery 4 weeks after last neoadjuvant chemotherapy treatment

6 cycles chemotherapy with Oxaliplatin 85 mg/m\^2 and Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 and 5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusionq2w + Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (6th cycle without Aflibercept) followed by surgery 4 weeks after last neoadjuvant chemotherapy treatment

Oxaliplatin 85 mg/m\^2, as 2h infusion on Day 1 (Arm A + Arm B)

5-FU 400 mg/m\^2 i.v. as bolus on Day 1 and 2400 mg/m\^2 as 46 h infusion q2w (Arm A + Arm B)

5-FU

Leucovorin 350 mg/m\^2 i.v. as 2h infusion on Day 1 (Arm A + Arm B)

Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (Arm B, Cycles 1 to 5)

Ralf-Dieter Hofheinz, Prof. Dr.

Patients with locally advanced rectal or rectosigmoid cancer staged cT3 CRM-negative with MRI will receive 6 cycles of neoadjuvant treatment with mFOLFOX6 (Arm A) vs. mFOLFOX6 + aflibercept (Arm B) followed by surgery.

Patients with locally advanced rectal cancer are generally recommended to receive preoperative radiotherapy or radiochemotherapy. The advantage of combined-modality therapy in rectal cancer is that it has reduced local pelvic recurrence - a dreaded and morbid event - to rates of about 10%. There is good quality evidence that preoperative radiotherapy reduces local recurrence but there is little if any impact on overall survival. One strategy to reduce the distant recurrence rate, and thereby increase the cure rate, would be to introduce systemic treatment earlier to prevent dissemination of micrometastases. The present trial is designed to compare two neoadjuvant chemotherapy regimens in patients with non-metastatic T3 CRM-negative rectal cancers using quality-controlled MRI of the pelvis as a main inclusion criterion. This strategy is believed to reduce acute and long-term toxicity caused by preoperative radiotherapy and to administer effective systemic chemotherapy early in the course of disease as neoadjuvant chemotherapy.

mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer

mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer: a Randomized Phase-II-trial

number of patients with a pCR finding divided by the number of patients in the analysis set pCR will be assessed in a standardized manner independently by a central pathology

The dose intensities of study medication will be calculated over the whole study duration and will be summarized descriptively by summary statistics.

AEs will be coded according to the NCI-CTC Criteria Version 4.03. For the analysis, all AEs will be classified as related and not related. AEs will be summarized by presenting the number and percentages of patients having any AE and having an AE in each NCI-CTC category. Summaries will also be presented for AEs by severity and relationship to study medication. Tables will be broken down by study arm. All deaths and serious adverse events will be listed and briefly described.

Summaries will also be presented for AEs by severity and relationship to study medication. Tables will be broken down by study arm.

All deaths and serious adverse events will be listed and briefly described.

For relevant laboratory parameters, the distribution over time as well as changes from randomization will be calculated and analyzed descriptively.

The R0- and R1 resection as well as downstaging and downsizing using a standardized regression grading (Dworak regression grading) will be analyzed descriptively by means of frequencies and percentages.

Disease-free survival rate will be analyzed using a two-sided Fisher's exact test at a 5% significance level. In addition, two-sided 95% confidence intervals for DFS rates and difference in rates between both treatment arms will be calculated.

Relapse-free survival: The length of time after completion of primary treatment (neoadjuvant chemotherapy + surgery) until documented relapse (i.e. local relapse, liver metastasis, systemic metastases).

Overall survival: Survival will be calculated from the date of subject enrollment until the date of death from any cause. If no event is observed (e.g. lost to follow-up) OS is censored at the day of last subject contact.

Perioperative medical events as well as mortality within 28 days after surgery will be summarized by frequencies and percentages broken down per treatment arm.

Vital signs will be analyzed using summary statistics broken down per treatment group and visit.

Physical examination as well as WHO/ECOG will be analyzed by calculating frequencies and percentages broken down per treatment group and visit.

Institut für Klinisch-Onkologische Forschung (IKF) Frankfurt

Sanofi

AIO-Studien-gGmbH

Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity.

Participants will perform a baseline +4000 steps/day for the duration of the study. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise.

Physical Activity

Participants will complete a series of survey at multiple points throughout this study to assess quality of life issues. Questionnaires may be completed via paper forms with prepaid postage envelopes or using a REDCap online survey.

Survey

Participants will meet with a health coach, the Principal Investigator, to review baseline bowel habits and symptoms as well as discuss physical activity and potential strategies to achieve this goal, on a weekly basis for 12 weeks.

Telehealth Lifestyle Coaching

Erica Pettke, MD, MPH, FACS

The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life.

Participants will be asked to:

1. Complete surveys to assess bowel function and quality of life
2. Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
3. Perform daily physical activity

The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.

Physical Activity in Rectal Cancer Survivors

Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors

Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).

Using qualitative methods, evaluate the acceptability of and satisfaction with the intervention as reported by survivors. After completion of the intervention or decision to discontinue participation, we will administer a semi-structured exit interview to evaluate the acceptability of the intervention.

Using the Memorial Sloan Kettering bowel function instrument administered pre-post PA intervention, describe the change in total bowel symptom score in the pilot cohort.

Abramson Cancer Center at Penn Medicine

Physician

Herbal and Botanical

Cola

The training set is a dataset used to train the model, which includes randomly enrolled patients with colon and rectal cancer. The inputs include data such as gender, age, height, weight, BMI, tumor stage, tumor pathology type, and the output information is whether NOSES surgery was successful or not. During training, the model learns from this dataset to make predictions on whether new patients with colon and rectal cancer can undergo NOSES surgery successfully.

The test set is a dataset used to evaluate the performance of a trained machine learning model. It includes another randomly enrolled group of patients with colon and rectal cancer, as well as their clinical and pathological data and surgical outcomes. The outputs are not used during training, but are used to test the trained model to evaluate its predictive ability on unknown data. The purpose is to evaluate the model's generalization ability, that is, its performance on new and unknown data.

Natural Orifice Specimen Extraction Surgery (NOSES) is a minimally invasive surgical technique that aims to reduce the size and number of incisions required during certain surgeries. In NOSES, the surgical specimen (such as a diseased organ or tumor) is removed from the body through a natural orifice (such as the mouth, anus, or vagina), rather than through an incision in the abdominal wall. In this trial, we will extract surgical specimens from the rectum to reduce trauma to the abdominal wall.

Natural Orifice Specimen Extraction Surgery

Yanxin Luo, PhD,MD

Yaoyi Huang, BS

The goal of this observational study is to test in patients with resectable rectosigmoid cancers. The main question it aims to answer is establishment of a feasibility model for predicting natural orifice specimen extraction surgery (NOSES) based on machine learning.

Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning

Establishment of a Feasibility Model for Predicting Natural Orifice Specimen Extraction Surgery (NOSES) Based on Machine Learning.

Accuracy will be calculated by the number of successful operations performed

Accuracy will be calculated by the number of successful operations actually completed.

Sixth Affiliated Hospital, Sun Yat-sen University

Principal Investigator

Colonic Diseases

Patients undergoing laparoscopic surgery using ArtiSential

ArtiSential

Jung Wook Huh, MD PhD

Dae HEe Pyo, MD PhD

Sun Wha Kim

Dae Hee Pyo, MD, PhD

Jung Wook Huh, MD, PhD

This study is to validate the safety and feasibility of ArtiSential (Articulating laparoscopic instrument) colorectal surgery and compare it with robotic surgery for patients with rectal cancer and rectosigmoid junction cancer.

A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry

conversion, postoperative complications, or less than 12 harvested lymph nodes

Total medical cost during hospital stay for surgery

Asan Medical Center

Seoul St. Mary's Hospital

Chonnam National University Hospital

Severance Hospital

Seoul National University Bundang Hospital

Uijeongbu St. Mary Hospital

LivsMed

Samsung Medical Center

Professor

A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion

A low anterior resection will be performed according to the surgeon's standard practice

PINPOINT

SPY Elite

Michael J Stamos, MD

Steven Wexner, MD

This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure

Rate of postoperative abscess requiring surgical management.

Novadaq Technologies ULC, now a part of Stryker

Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.

PINPOINT or SPY Elite

STANDARD

Not treated by either perfusion (PINPOINT/SPY Elite) or standard treatment.

Not Treated

Total

Mean

Age, Customized

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

Height

Weight

Smoking Status

Alcohol Consumption

The Model for End-Stage Liver Disease (MELD) consists of serum bilirubin, creatinine levels, International Normalized Ratio (INR) for prothrombin time, and Serum Sodium levels. Subjects with hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score \>12 were excluded from the study. The MELD score can range from 6 to 40 with higher numbers indicating more severe disease.

MELD Score (Model for End-Stage Liver Disease)

Long-Course Neoadjuvant Therapy

Pre-Operative Diagnosis

The interpretation of the efficacy results is limited due to the fact that the study was stopped early, which may have adversely affected the statistical power of some tests.

Alicia Wilton

Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer	NCT03043729	Rectal Cancer Rectosigmoid Ca...	Oxaliplatin 5-FU Leucovorin Aflibercept	18 Years -	AIO-Studien-gGmbH
Physical Activity in Rectal Cancer Survivors	NCT06435975	Rectal Cancer Rectosigmoid Ca...	Physical Activi... Survey Telehealth Life...	18 Years -	Abramson Cancer Center at Penn Medicine
mFOLFOX6 vs. mFOLFOX6 + Aflibercept as Neoadjuvant Treatment in MRI-defined T3-rectal Cancer	NCT03043729	Rectal Cancer Rectosigmoid Ca...	Oxaliplatin 5-FU Leucovorin Aflibercept	18 Years -	AIO-Studien-gGmbH
Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning	NCT05797064	Machine Learnin... Surgery Rectosigmoid Ca... Natural Orifice...	Natural Orifice...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry	NCT05566249	Rectal Cancer Rectosigmoid Ca... Rectosigmoid Ju...	ArtiSential	18 Years - 80 Years	Samsung Medical Center
Physical Activity in Rectal Cancer Survivors	NCT06435975	Rectal Cancer Rectosigmoid Ca...	Physical Activi... Survey Telehealth Life...	18 Years -	Abramson Cancer Center at Penn Medicine
Establishment of a Feasibility Model for NOSE Surgery Based on Machine Learning	NCT05797064	Machine Learnin... Surgery Rectosigmoid Ca... Natural Orifice...	Natural Orifice...	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection	NCT02205307	Rectal Cancer Rectosigmoid Ca...	PINPOINT SPY Elite	18 Years -	Novadaq Technologies ULC, now a part of Stryker
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry	NCT05566249	Rectal Cancer Rectosigmoid Ca... Rectosigmoid Ju...	ArtiSential	18 Years - 80 Years	Samsung Medical Center
Physical Activity in Rectal Cancer Survivors	NCT06435975	Rectal Cancer Rectosigmoid Ca...	Physical Activi... Survey Telehealth Life...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for rectosigmoid cancer