Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Infections

Colonic Neoplasms

Syndrome

Inflammation

Peritonitis

Systemic Inflammatory Response Syndrome

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Shock

Communicable Diseases

Intraabdominal Infections

Peritoneal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients undergoing robotic-assisted colectomy for colonic neoplasm

Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology

Robotic-assisted colectomy

Conventional laparoscopic colectomy

Pedja Cuk, MD

The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial

Levels of cytokines are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A as well as IL-1RA and CRP. All cytokines are measured in pg/mL, CRP measured in mg/L

Recovery is measured according to quality of recovery 15 score (QoR-15). The score ranges from 0-150. A high score indicates a good recovery.

Number of mortality obtained from medical charts

The heart rate will continuously recorded by ECG intra- and postoperatively

The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence

The cytokine levels are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A and IL-1RA. All cytokines are measured in pg/mL

Number of complications obtained from medical records

Region of Southern Denmark

University of Southern Denmark

Wounds and Injuries

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Hyperthermia

Abdominal Neoplasms

Fever

Mesothelioma

Mesothelioma, Malignant

Peritoneal Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Antineoplastic Agents

Anti-Inflammatory Agents

Pharmaceutical Solutions

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Fluorouracil

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cisplatin

Diphenhydramine

Promethazine

Pancrelipase

Pancreatin

Ranitidine

Ranitidine bismuth citrate

Tubulin Modulators

Antimitotic Agents

Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.

Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.

Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.

Patients will undergo cytoreductive surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected.

Surgery

Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin

Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will be delivered in the early postoperative period (day 7 today 12 after surgery). Patients will be premedicated with hydrocortisone (100 mg/intravenous push (i.v.p.)), diphenhydramine (50 mg i.v.p.) and ranitidine (50 mg i.v.p.) 30 minutes prior to delivering intraperitoneal chemotherapy. One liter of normal saline will be infused containing 5-FU (800 mg/M\^2) and 1 L of normal saline containing paclitaxel (125 mg/M\^2) will be infused over 60 minutes. The chemotherapy solution will be left in the abdominal cavity permanently for slow absorption.

Postoperative dwell with paclitaxel and 5-FU

Marybeth S Hughes, M.D.

This study will test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor, perfusion of the abdomen during surgery with a heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the abdomen with fluorouracil (5-FU) and paclitaxel.

Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic resonance imaging (MRI), and chest, abdomen and pelvic CT scans.

Participants undergo surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. During surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 108.6 degrees (10 degrees above normal body temperature) is then delivered into the abdomen through one catheter and drained through another. During treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed. Another small catheter is then placed and left inside the abdomen with one end coming out through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and paclitaxel are given through this catheter.

After complete recovery from the surgery, the catheter is removed and the patient is discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination, imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long as the disease does not worsen. Patients whose disease progresses are taken off the study and referred back to their local physician or referred for alternative care or other research studies.

Patients are also asked to assess how this therapy affects their general health and well being. This will require filling out two quality-of-life (QOL) questionnaires before surgery and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to complete.

Background:

Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis. The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin plus early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel after cytoreductive surgery for peritoneal carcinomatosis.

Objectives:

The primary objective of this study is to determine response and survival after continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel. Response can only be assessed by measuring the time to clinical or radiographic recurrence of disease.

The secondary objectives include the determination of pharmacokinetics of paclitaxel and 5-FU delivered into the peritoneal cavity and the impact that continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel has on patients' health related quality of life.

The evaluation of pure populations of tumor and normal mesothelial cells to

* determine if signal transduction pathways are distinct in tumor versus normal tissue
* to see if specific cell pathways are activated or inhibited as a consequence of therapy.
* to validate that this technology can provide informative data about these events as a potential surrogate for clinical benefit from therapy or biological behavior of the tumor.

Eligibility:

The patient greater than or equal to 30 kg must have histologically proven peritoneal carcinomatosis from one of the following histologies: 1) primary peritoneal mesothelioma; 2) low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); 3) adenocarcinoma of gastrointestinal tract origin (other than low grade mucinous, excluding pancreatic cancer), with disease confined to the peritoneal cavity. Patients may not have had treatment for their disease within the previous 30 days and have recovered from all toxicity. Patients must meet certain safety laboratory criteria and may not have major medical disorders that would place them at unacceptable risk for a major surgical procedure. Patients may not have received prior intraperitoneal platinum therapy.

Design:

Patients will undergo cytoreductive surgery followed by CHPP with cisplatin. A peritoneal dialysis catheter will be inserted into the peritoneal cavity at the time of laparotomy. In the early postoperative period (day 2 - 10) intraperitoneal dwell chemotherapy with paclitaxel (125 mg/M\^2) and 5-FU (800 mg/M\^2) will be administered. Patients will be seen 4 - 6 weeks after discharge for a physical examination and laboratory screen and QOL evaluation. Tumor marker will be included at this stage. Patients will then be seen every 3 months for the first year after surgery and every 6 months thereafter. At each visit they will undergo physical examination, laboratory screening (including tumor marker) and a CT scan of the chest, abdomen and pelvis and QOL evaluation.

The objective of this pilot study is to estimate the ability of peritoneal perfusion to achieve potentially tolerable disease free survival in patients with a variety of tumors. For each class of tumors, an appropriate, distinct median disease free survival will be targeted as the principal endpoint. The trial will be conducted as a set of three single-stage phase II studies, with an early stopping rule for clearly unacceptable outcomes. It is expected that accrual for 59 patients with adenocarcinoma of gastrointestinal origin (other than low grade mucinous), 48 patients with low grade mucinous adenocarcinoma, and 96 patients with primary peritoneal mesothelioma (total accrual of 203) will require approximately 5 -6 years.

Results will be assessed by following the time to radiographic or clinical recurrence of disease and survival. Patients will be stratified for entry based on histology. This will include 3 cohorts: 1) peritoneal mesothelioma; 2) low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); and 3) adenocarcinoma of gastrointestinal origin (other than low grade mucinous).

Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy

Phase II Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-Fluorouracil for Peritoneal Carcinomatosis

Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.

Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).

The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time.

For detailed information about the questionnaires, please see the Protocol Link module.

Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.

National Cancer Institute (NCI)

Principal Investigator

Adverse Events: 188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P.Meso + 48 L.Grade + 57 Adeno. = 188).

Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.

Mesothelioma, Low Grade, and Adenocarcinoma

Peritoneal Mesothelioma

Low Grade Mucinous Adenocarcinoma

Adenocarcinoma of Gastrointestinal Origin

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

White

Hispanic

African American

Asian American

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Marybeth S. Hughes, M.D.

This outcome measure was not analyzed because information was not consistently available.

Number of Participants With Disease-free Survival

Number of Participants With a Response

188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).

Number of Participants With Adverse Events

This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).

Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed

This outcome measure was not evaluated due to poor patient compliance.

Quality of Life Questionnaire Score

Normal Tissue

Tumor Tissue

This outcome measure was not analyzed because it was not feasible.

Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue

Overall Study

Polyps

Narrow band imaging

Wai Keung Leung, MD

Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in the right side colon have been suggested to be the cause for interval cancer that developed after a prior negative colonoscopy.

Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been developed to improve colonic polyp detection. However, it remains controversial whether the previous version of NBI helps to improve colonic polyp detection. The new generation colonoscope is equipped with high definition and improved narrow band imaging (NBI) which gives at least twice the viewable distance and contrast. The images obtained are far brighter with better resolution than the previous version. It however remains to be determined whether this enhanced imaging technique could help to improve colonic polyps detection.

Hypothesis:

The new generation NBI increases the detection rate of proximal serrated polyps and reduces the missed rate of all colorectal polyps.

Aims:

* To determine whether the new generation NBI improve the detection rate of proximal serrated polyps.
* To determine whether the new generation NBI improve the detection rate of all colorectal adenoma and polyps.
* To determine whether the new generation NBI reduce the miss rate of colorectal adenoma and polyps.

Design:

Prospective randomized trial

Inclusion:

• All patients scheduled to have screening or scheduled colonoscopy

Exclusion:

* History of Crohn's or ulcerative colitis
* Surveillance for known polyposis syndrome (FAP or HNPCC)
* Previous colonic resection (except appendectomy)
* Refused consent
* Deranged coagulation profile that preclude polypectomy

Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Colonoscopy With Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

No. of patients with proximal serrated polyps

Missing rate for proximal serrated polyps

The University of Hong Kong

Clinical Professor

Behaviors and Mental Disorders

Quality of Life

All patients presenting with a newly diagnosed colon cancer regardless of tumour stage

There is no intervention, only observation

Eva Angenete, M.D., Ph.D.

All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

QoLiCOL - Quality of Life in Colon Cancer

The primary end-point is to describe QoL, symptoms and functional impairments in an unselected population of colon cancer patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer	NCT04687384	Colonic Neoplas... Colon Cancer Systemic Inflam... Inflammation Robotic Surgica... Laparoscopy Peritoneal Infl...	Robotic-assiste... Conventional la...	18 Years -	University of Southern Denmark
Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy	NCT00004547	Abdominal Neopl... Colonic Neoplas... Mesothelioma Peritoneal Neop...	Surgery Continuous hype... Postoperative d...	18 Years -	National Institutes of Health Clinical Center (CC)
Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps	NCT01725321	Colonic Neoplas...	Narrow band ima...	40 Years -	The University of Hong Kong
QoLiCOL - Quality of Life in Colon Cancer	NCT02530593	Colonic Neoplas...	There is no int...	18 Years -	Sahlgrenska University Hospital, Sweden

Spots Global Cancer Trial Database for colonic neoplasm