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FOLFOX

TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.

total mesorectal excision (TME)

Peter Kozuch, MD

A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6.

The objectives of this study are the following:

1. The primary endpoint of this trial is pathologic complete response (response rate).
2. Secondary endpoints will include observation of overall pathologic response rate, correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging, as well as observation of toxic side effects, patterns of disease relapse, disease-free survival outcomes and overall survival outcomes.

Principal Investigator: Peter Kozuch, M.D.

Sites: BIMC/SLRHC

Introduction

A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6.

The objectives of this study are the following:

1. The primary endpoint of this trial is pathologic complete response (response rate).
2. Secondary endpoints will include observation of overall pathologic response rate, correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging, as well as observation of toxic side effects, patterns of disease relapse, disease-free survival outcomes and overall survival outcomes.

Background Locally advanced rectal carcinoma continues to be a major oncologic problem in the United States. Several landmark studies have led to the current standard approach to the care of patients with stage II and III rectal cancer. In 1990 adjuvant 5- fluorouracil based chemoradiation became the accepted standard of care on the basis of two randomized trials. During the following two decades significant modifications were made to both the administration of chemoradiation therapy and surgery. First, continuous infusion 5-fluorouracil daily concurrent with radiation to was shown to be superior to bolus 5-fluorouracil for 3 consecutive days during weeks 1 and 5 of radiation. The overall rate of tumor relapse fell from 47% to 37%, and distant metastasis rate fell from 40% to 31%. Notably, local tumor recurrence was not significantly different between the two chemotherapy schedules. The improvement in relapse rate translated into a 4 year survival benefit, 70% versus 60%, favoring the protracted venous infusion of 5-fluorouracil (5-FU).

What is not known, however, is the relative contribution of radiation therapy to survival outcomes in the setting of chemotherapy programs for rectal cancer. Optimization of systemic therapy appears to have the most significant impact on survival outcomes. Firstly, patients may begin full systemic therapy with the regimen that has currently been identified as the most effective adjuvant treatment of stage III colon cancer. This relatively prompt initiation of 'full systemic dose' chemotherapy is in stark contrast to the typical paradigm of a 3-4 week interval between initial consultation and initiation of chemoradiation. Another theoretical advantage of this proposed trial lies in the fact that full systemic therapy is relatively uninterrupted. Therefore, the anticipated 6-8 week perioperative treatment free interval anticipated in this schema compares favorably with the typical 10-12 week perioperative treatment free interval with current standard of care neoadjuvant chemoradiation. Another important consideration favoring this chemotherapy is substantially less travel time/treatment time for patients and favorable toxicity profile given the elimination of daily neoadjuvant radiation.

Treatment Plan

Patients will be given:

* Modified FOLFOX6 will be given neoadjuvantly prior to resection for 3 months (6 cycles)
* Modified FOLFOX6 will be given adjuvantly within 6 weeks following resection for 3 months (6 cycles)

Neo-Adjuvant FOLFOX for Rectal Carcinoma

A Phase II Open- Labeled, Prospective Study to Determine the Efficacy of Pre- Operative Chemotherapy With Six Cycles of Modified FOLFOX 6 Followed by Total Mesorectal Excision (TME) Followed by an Additional Six Cycles of FOLFOX 6

St. Luke's-Roosevelt Hospital Center

Beth Israel Medical Center

total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.

FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6

6 Cycles of FOLFOX Pre and Post TME

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Study terminated prior to data collection of time frame

Pathologic Complete Response

Observation of Overall Pathologic Response Rate, Correlation of Pathologic Staging With Pre-op Ultrasound and Pelvic MRI Staging Observed Toxicities Patterns of Disease Relapse Disease-free Survival Overall Survival

Overall Study

Colonic Diseases

Caiman 5 articulating Maryland

Niedergethmann, Prof. Dr. med.

This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.

CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study

Time between first incision and closure of the surgical incision

Number of Complications: Wound infections, Urinary tract infections, Pulmonary infections, Other infections, Wound dehiscence, Anastomotic leak, Anastomotic bleeding, Other bleeding / hemorrhage, Intraabdominal abscess, Fistula, Peritonitis, Sepsis, Hernia, Stenosis Ileus, Ureter injury, Nerve injury, Cardiac complications, Other

Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)

Time between end of left flexure mobilization and stapling

Time \[in minutes\] between end of left flexure mobilization and stapling

Time \[in minutes\] between end of ileocolic vessels clipping and start of right flexure mobilization

Time \[in minutes\] between end CME and start of resection of the mesentery of the small intestine

Time \[in minutes\] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding)

Number of days postoperative until discharge from intensive care unit

Number of days postoperative until discharge from intermediate care unit stay

Number of days until patient's first postoperative oral intake

Number of days until patient's first postoperative stool after oral intake

quality of mesorectal excision according to criteria established in the "Magnetic Resonance Imaging and Rectal Cancer European Equivalence Study" (M.E.R.C.U.R.Y.)

Aesculap AG

Bevacizumab

Capecitabine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Neoadyuvant chemotherapy with XELOX: Xeloda 1000mg/m2/12h dayly, day one in the afternoon until day 15 in the morning; plus oxaliplatin 130mg/m2 (day 1); and Bevacizumab 7.5 mg/kg (day 1)during 3 cycles (each cycle of 3 weeks).

Followed by a selective use of chemoradiotherapy with radiotherapy (50.4Gy, 28 sesions of 1.8Gy during 5 weeks) plus Xeloda 825mg/m2/12h dayly.

PO 1000 mg/m2 bid during day 1 to 15 for 3 cycles (every cycle has 3 weeks)

IV 130 mg/m2 during day 1 for 3 cycles (every cycle has 3 weeks)

IV 7.5 mg/Kg during 30 minutes day 1 during 4 cycles (every cycle has 3 weeks)

Total dose 50.4 Gy administered during 28 days (1.8 Gy/day in 5 weeks).

Radiotherapy

Capecitabine during all Radiotherapy period

4 weeks from the last chemotherapy dose. In those patients who receive radiation TME wil be performed six weeks after

Total Mesorectal Excision (TME)

Carlos Fernández Martos, Oncologist

Carles Pericay, Oncologist

Antonieta Salud, Oncologist

Vicente Alonso, Oncologist

María José Safont, Oncologist

Ruth Vera, Oncologist

Pilar Escudero, Oncologist

Joan Maurel, Oncologist

Jorge Aparicio, Oncologist

Jaime Feliú, Oncologist

Mengual, Radiotherapy

Moisés Miraflores, Radiotherapy

Martín Tejedor Gutierrez, Radiotherapy

Ana Hernández Machancoses, Radiotherapy

Fernando Arias de la Vega, Radiotherapy

Javier Valencia, Radiotherapy

Carles Conill, Radiotherapy

Alejandro Tormo Micó, Radiotherapy

María Elena Sánchez Santos, Radiotherapy

Jorge Campos, Surgeon

Enrique Sierra Grañón, Surgeon

Andrés Monzón, Surgeon

José Vicente Roig, Surgeon

Javier Suárez Alecha, Surgeon

Eloy Tejero, Surgeon

Antonio Lazy, Surgeon

Rafael Estevan, Surgeon

Damián García Olmo, Surgeon

Jesús Santos, Radiologist

Ana Darnell, Radiologist

Luís Sarriá, Radiologist

Vicente Martínez Sanjuán, Radiologist

Javier Jiménez, Radiologist

José Antonio Fernández Gómez, Radiologist

Juan Ramón Ayuso, Radiologist

Fernando Mas Estellés, Radiologist

Paula Alegría Hidalgo, Radiologist

Anna Caltrava, Pathologist

Alex Casalots, Pathologist

Xavier Matias-Guiu Guia, Pathologist

Carlos Hörndler, Pathologist

Encarna Martínez, Pathologist

María Luisa Gómez Dorronsoro, Pathologist

Javier Ortego, Pathologist

María José Artes, Pathologist

Marta Martín Richard, Oncologist

Manuel Gallén, Oncologist

Javier Gallego, Oncologist

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.

XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX without Bevacizumab will be administrated for an additional cycle over a 4 week period. Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous Capecitabine.

Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging

Complete pathologic response (pCR)estimated according to the number of subjects that showed yPT0N0 divided by the total number of subjects.

Royal Marsden NHS Foundation Trust

Grupo Espanol Multidisciplinario del Cancer Digestivo

Patients who achieve Clinical complete response (cCR) or near-cCR when restaged at 16 weeks following IMRT plus consolidation CapeOX.

Patients with near-cCR or residual tumor ≤ycT2N0 when reassessed at 16 weeks following IMRT plus consolidation CapeOX; or Patients with regrowth ≤ycT2N0 when reassessed during surveillance in NOM;

Patients with residual tumor \&gt;ycT2N0 when restaged at 16 weeks following IMRT plus consolidation CapeOX.

or Patients with regrowth \&gt;ycT2N0 when reassessed during surveillance in NOM; or Patients with any high-risk pathological factors following local excision (LE)

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Nonoperative Management (NOM)

Nonoperative Management (NOM)

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Local Excision (LE)

Local Excision (LE)

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Total Mesorectal Excision (TME)

Xiaokang Lei, M.D.

Lin Wang, M.D.

The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are:

1. What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX?
2. Is LE or NOM safe and effective in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.

Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer

The rate of organ preservation will be defined as the percentage of patients who achieve cCR or near-cCR after neoadjuvant treatment followed by local excision or non-operative management (NOM). The time of organ preservation will be measured from the initiation of treatment.

NR-DFS will be defined as the length of time after treatment until death (any cause), tumor relapse including local pelvic recurrence following TME or local resection and any distant metastasis during or after treatment. Surgical salvageable local regrowth occurs in non-operative management will not be defined as tumor relapse.

Stoma-free survival will be defined as the length of time in which patients live with a temporary or permanent stoma and be measured from the initiation of treatment. Events for stoma-free survival are temporary or permanent stoma or death (any cause). Temporary ileostomy-free survival or colostomy-free survival will also be calculated.

Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Peking University Cancer Hospital & Institute

Unit III & Ostomy Service, Gastrointestinal Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Total Mesorectal Excision plus Lateral Lymph Node Dissection for low rectal cancer with regional lymph node metastasis.

Total Mesorectal Excision After Neoadjuvant Chemo-radiotherapy for low rectal cancer with regional lymph node metastasis.

patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)

TME+LLND

patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)

TME+nCRT

Yanxin Luo

Shaoyong Peng

Yanxin Luo, PhD,MD

Shaoyong Peng, MD

Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

There are significant differences between Japanese guidelines (JSCCR) and Western guidelines (NCCN, ESMO) in the treatment of low rectal cancer, especially in patients with regional lymph node metastasis. Japanese scholars advocated total meso rectal resection (TME) + Lateral lymph node dissection (LLND), However, European and American scholars advocate that only TME is used after new adjuvant chemo-radiation (nCRT), without LLND. Therefore, the purpose of this clinical trial was to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. This will provide a high level of clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy

Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis

From the date of operation until the date of complication,assessed up to 3 years

From the date of operation until the date of complication,assessed up to 3 months

The study investigate the quality of life using the WHOQOL Scale

Sixth Affiliated Hospital, Sun Yat-sen University

Adenocarcinoma

Central Nervous System Depressants

Anesthetics

Arm 1 will receive tailored surgery. If there are no cancer cells or the margin is negative in the local excision/biopsy during surgery, the operation will be terminated. And if the final pathology result is T2-4, or cancer cells and margin are positive in the frozen section during surgery, or the result of digital rectal examination and visual examination using anoretractor under general anesthesia is not suitable for local excision (visible and palpable tumor nodules), a total mesorectal excision will be performed.

Arm 2 will receive TME. Surgery including high ligation of the inferior mesenteric artery and total mesorectal excision will be performed under the lithotomy position. After pelvic dissection, double-stapled anastomosis or transanal anastomosis will be performed, followed by diverting stoma. Abdominoperineal resection with permanent stoma is included.

Procedure: Tailored surgery based on intraoperative local excision/biopsy

Tailored surgery

Procedure: Total mesorectal excision for all allocated patients

Total mesorectal excision (TME)

Sung-Bum Kang

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

Duck-Woo Kim, M.D., Ph.D.

Heung-Kwon Oh, M.D., Ph.D.

The purpose of this study is to show that tailored treatment based on local excision can expand the target of non-radical treatment in ycT2-3N0M0 patients after neoadjuvant chemoradiotherapy for low rectal cancer and that the oncologic safety is not inferior to that of total mesorectal excision.

Target number of subjects and calculation basis This study aims to show that the tailored treatment based on intraoperative local excision/biopsy is not oncologically inferior to total mesorectal excision. The 5-year overall survival rate expected from the existing standard treatment was 85% (van der Valk. 2018, Rullier. 2020). The non-inferior margin of the customized treatment was 10%, type 1 error 0.10, power 80%, 1:1 ratio. When calculated with a 10% dropout rate, a total of 346 people, 173 in each group, needs to be recruited.

Study Subject Recruitment Plan

1. Selection and enrollment of subjects: Subjects in clinical trials must be enrolled by the investigator before starting surgical treatment.
2. Document consent: To the patient who is considered to be able to participate in the clinical trial as a subject, an oral explanation of this clinical trial will be presented to the participants, and the written consent to participate in the clinical trial shall be obtained.
3. Preoperative evaluation A pre-treatment examination to determine the selection of subjects and their underlying condition will be conducted. Pre-treatment examination will be performed to review whether the subject meets the selection and exclusion criteria, and subjects with significant abnormalities will be excluded.

Control group setting and randomization method Tailored treatment based on local excision and total mesorectal excision are randomly assigned 1:1 by web-based random number table (REDCap).

Statistical Analysis The statistical analyses will be conducted using intention-to-treat, and per-protocol approaches. Multiple imputation for missing covariates will be performed to determine whether there are systematic differences in terms of missing data. Analyses of the primary and secondary outcomes will be adjusted for potential co-variates.

Results of the quality of life and sexual/urinary function questionnaires will be compared using linear generalized estimating equations (GEE), adjusted for baseline values, the time effect, and the interaction effect between time and treatment.

Clinical and pathological variables will be compared using χ2 tests or Fisher's exact test for categorical variables, or with Student's t-test for continuous variables. Disease-free survival, relapse-free survival, and overall survival curves will be plotted using the Kaplan-Meier method, and differences in survival curves will be compared using the log-rank test. Multivariable analyses using the Cox regression hazard model will be conducted to identify the factors that are independently associated with disease-free survival, relapse-free survival, and overall survival. All statistical tests will be two-sided and values of p\<0·05 will be considered statistically significant.

Comparison Between Tailored Surgery Versus Total Mesorectal Excision in ycT2-3N0M0

Comparison of Oncologic Outcomes Between Tailored Surgery According to Intraoperative Local Excision Biopsy Versus Total Mesorectal Excision in ycT2-3N0M0 on Magnetic Resonance Imaging After Neoadjuvant Chemoradiotherapy for Low Rectal Cancer

The percentage of people in a study or treatment group who are alive five years after their diagnosis or the date of randomization

Postoperative recovery index, surgery-related complications, and mortality comparison (Clavien-Dindo classification III-V), histopathologic examination of the proximal/distal/peripheral margins

Rate of Disease-free Survival/Relapse-free Survival/Stoma-free Survival/Regrowth-free Survival through physical examination including digital rectal examination, carcinoembryonic antigen test (CEA), liver function test (AST/ALT), chest and abdominal CT and colonoscopy

The Korean version of EORTC QLQ 30 which is an evaluation instrument for the quality of life of cancer patients, and the Korean version of EORTC QLQ-CR29 which is an evaluation instrument for the quality of life of colon cancer patients.

IPSS (International Prostate Symptom Score) for urinary function test, IIEF-5 (5-item Version of the International Index of Erectile Function) for male sexual function test, FSFI (Female Sexual Function Index) for female sexual function test.

MSKCC questionnaire, fecal incontinence severity index (FISI), low anterior resection syndrome (LARS) score questionnaire and fecal incontinence quality of life index (FIQL), manometry

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neo-Adjuvant FOLFOX for Rectal Carcinoma	NCT00832299	Rectal Neoplasm...	FOLFOX total mesorecta...	18 Years - 70 Years	Beth Israel Medical Center
CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery	NCT04175756	Colorectal Canc...	Caiman 5 articu...	18 Years -	Aesculap AG
Study of Neoadjuvant CT With Selective Radiotherapy in Patients With Intermediate-Risk Cancer Rectum	NCT00909987	Rectum Cancer	Capecitabine Oxaliplatin Bevacizumab Radiotherapy Capecitabine du... Total Mesorecta...	18 Years -	Grupo Espanol Multidisciplinario del Cancer Digestivo
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer	NCT06209099	Rectal Cancer	Nonoperative Ma... Local Excision ... Total Mesorecta...	18 Years - 85 Years	Peking University Cancer Hospital & Institute
Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy	NCT03587480	Rectal Neoplasm...	TME+LLND TME+nCRT	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Comparison Between Tailored Surgery Versus Total Mesorectal Excision in ycT2-3N0M0	NCT05164315	Rectal Cancer, ...	Tailored surger... Total mesorecta...	18 Years - 80 Years	Seoul National University Hospital
Neoadjuvant Radiotherapy Followed by Transanal Endoscopic Microsurgery for T1-T2 Extraperitoneal Rectal Cancer	NCT02127645	RECTAL CANCER	SRT-TEM LRT-TEM Transanal Endos... Total Mesorecta...	18 Years - 90 Years	European Association for Endoscopic Surgery
Comparison Between Tailored Surgery Versus Total Mesorectal Excision in ycT2-3N0M0	NCT05164315	Rectal Cancer, ...	Tailored surger... Total mesorecta...	18 Years - 80 Years	Seoul National University Hospital
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer	NCT06209099	Rectal Cancer	Nonoperative Ma... Local Excision ... Total Mesorecta...	18 Years - 85 Years	Peking University Cancer Hospital & Institute
Neo-Adjuvant FOLFOX for Rectal Carcinoma	NCT00832299	Rectal Neoplasm...	FOLFOX total mesorecta...	18 Years - 70 Years	Beth Israel Medical Center

Spots Global Cancer Trial Database for total mesorectal excision (tme)