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Intestinal Neoplasms

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Colonic Diseases

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Cola

Multivisceral resection for locally advanced colon cancer.

Multivisceral resection

The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).

All patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) Data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a T4 (a or b) tumour on postoperative histopathology.

Data included are patient demographics, ASA score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including TNM scoring, completeness of surgical procedure (R0 to R2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.

Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.

Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis. (LACC Trial)

Data will retrospectively collected from a maintained database in each center, created by the. A local study manager will be identified for each participating center.

I evaluate peri and post-operative surgical (e.g. intraabdominal collection, fistula, anastomotic leak) and medical (e.g. pneumoniae, deep vein thrombosis) complications

I evaluate in-hospital and 30-day mortality correlate to the intervention

The length of time from the intervention that patients diagnosed with a T4 colon cancer are still alive.

The measure of time after treatment during which no sign of recurrence (local or metastatic) is found.

Santo Spirito Hospital, Italy

Dirigente Medico I livello Chirurgia Generale

Patients who underwent laparoscopic multivisceral resection for clinical T4b colorectal cancer

Patients who underwent open multivisceral resection for clinical T4b colorectal cancer

The laparoscopic approach was used for the treatment of clinical T4b colorectal cancer

Laparoscopic surgery

This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.

Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.

Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).

Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.

Hospital stay after surgery is defined as the length of time from the end of surgery to the discharge of patient, which is measured in days.

Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.

Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Associate professor

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Alessandro Gronchi, MD

Marco Fiore, MD

William Tseng, MD

Sanjay Bagaria, MD

John Mullinax, MD

Kenneth Cardona, MD

Chan Raut, MD

Raphael Pollock, MD

David Gyorki, MD

Mai-Kim Gervais, MD

Carolyn Nessim, MD

Carol Swallow, MD

Sylvie Bonvalot, MD

Peter Hohenberger, MD

Markus Albertsmeier, MD

Dario Callegaro, MD

Marco Rastrelli, MD

Tommaso Campagnaro, MD

Sung Jo Kim

Piotr Rutkowski, MD

Marko Novak, MD

Juan Angel Fernandez, MD

Samuel Ford, MD

Dirk Strauss, MD

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.

Primary Objectives of this study are:

* to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers.
* patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).

Secondary Objectives:

* to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS;
* to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy;
* to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease;
* to utilize collected pathological material for research collaborations.

Retroperitoneal sarcomas (RPS) are rare tumors accounting for 10-15% of all soft tissue sarcomas (STS). They arise between retroperitoneal organs and among vital structures (ie major abdominal vessels) in an anatomical compartment that is not readily accessible by physical examination. Four main histotypes account for about 80% of all cases: well-differentiated liposarcoma (WDLPS), dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS) and solitary fibrous tumor (SFT).

Compared to sarcomas at other anatomic sites, RPS are burdened by a higher local recurrence (LR) rate (50% at 5 years) and a poorer overall survival (OS) rate (50% at 5-years). The natural history of RPS as a whole group reflects the strong tendency of lipomatous tumors (WDLPS and DDLPS, which account for about 50% of RPS) to recur locally. Indeed, outcome of primary RPS is highly related to the histological subtype.

WDLPS are characterized by a relatively lower LR rate, negligible metastatic potential and a favorable overall survival. These tumors however, still may recur locally even years after the primary resection. Intermediate grade DDLPS are characterized by a strong tendency to recur locally and low metastatic potential. High grade DDLPS has a high risk of both local recurrence and distant metastasis. LMS are usually intermediate or high-grade tumors with a strong tendency to develop distant metastasis; with an adequate resection, it is relatively common to obtain a durable local control. Classic SFT usually fare well after surgery, with a low rate of local recurrence and distant metastasis.

Historically, surgery emerged as the only potentially curative option in the localized setting. In the last few years there has been lively debate as to how far should a surgeon resect in order to obtain a margin that could be considerate adequate. This issue is particularly challenging in this anatomical compartment where widening the surgical margins means resecting adjacent organs.

Since 2002 an 'extended' surgical approach has been proposed for primary RPS patients. The concept was that surgical margins could be improved by encompassing the tumor with en-bloc resection of adjacent organs. The aim was to obtain reduced local recurrence and improved survival. This approach has proven to be effective. In particular, this surgical approach has been supported by an experimental model, retrospective comparisons, pathology studies demonstrating adjacent organ involvement, and reports of high rates of residual tumor at re-excision after conventional (non-extended) primary surgery. Finally, this approach has been shown to be safe after both short and long term follow-up.

Radiotherapy is an option for RPS, especially in the preoperative setting, but currently the best evidence for efficacy comes form retrospective, mainly single-center, small size series. The results of such studies are controversial and high quality data are lacking. A randomized prospective study led by EORTC (STRASS) is ongoing but results are not expected for several years.

The role of chemotherapy in the localized disease is also still under investigation, especially in high grade tumors. So far, there is no agreement on the optimal treatment strategy, even within reference centers, regarding the use of both chemo- and radiotherapy. In the recent years European and North-American centers joined the panel of expert and this led to the formation of the TransAtlantic Retroperitoneal Sarcoma Working Group (TARPSWG), which now consists of more than 50 representatives from sarcoma centers from all over the world.

The aim of this collaboration is to expand the knowledge of the disease and formulate shared, standardized principles of treatment. A retrospective study has been carried out and recently published by the group to better define patients' outcome and prognostic factors after surgical resection of primary tumors. Other retrospective studies have been published focusing on post-relapse outcome, postsurgical morbidity and local recurrence treatment. This collaboration has also just recently led to the development of consensus guidelines for the treatment of primary and recurrent and metastatic RPS.

To take advantage of the group collaboration, TARPSWG promoted a prospective collection of clinical, radiological and pathologic data for RPS.

This study is aimed to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).

STUDY DESIGN

This is a prospective, multicentric observational study under the supervision of TARPSWG (TransAtlantic Retroperitoneal Sarcoma Working Group) aimed to prospectively collect clinical data and prospectively store radiological and pathological material from patients affected by primary RPS treated with surgery.

Patients with a diagnosis of primary RPS who meet the eligibility criteria will be invited to participate to the current study.

Eligible patients will receive full information on the type of surgery proposed and on the data and material (radiological and pathological) that will be collected. Eligible and informed patients who give their consent to participate will be included in the Prospective Cohort Study (PCS) and will be followed-up prospectively.

A data collection form including patient and tumor-related factors, treatment variables, follow-up findings, development of and time to local recurrence and status at follow-up has been constructed and shared among all the participating centers.

Each participating reference center will individually be able to have access to both cross sectional imaging (CT or MRI images) and pathological material (a representative formalin block of the tumor). Whenever possible patient identifiers will be removed and patient confidentiality will be maintained. Any data shared between institutions will be deidentified and all measures to conceal patient identifiers will be taken.

Each center will be responsible for data-entry and storage of its own patients' data, radiological examinations and pathological samples. At the time of the analysis each center is committed to provide the requested updated data to the group.

Follow-up will be based on clinical evaluation and on cross sectional imaging (CT scan of the thorax and abdomen and/or contrast enhanced MRI of the abdomen) every 4 months for the first 2 years, every 6 months until the 5th year and yearly thereafter.

The overall duration of the project has not been fixed.

Sample size

The number of patients we plan to include in this prospective multicenter study will be 400 patients per year.

STATISTICAL CONSIDERATIONS Continuous variables will be summarized with appropriate summary statistics such as the mean, median, standard deviation, minimum and maximum. Categorical variables will be tabulated with frequencies and percentages. We will evaluate OS, DFS, CCI of DM and LR and correlate this with clinicopathologic factors such as histology, grade, type of surgery, etc.

DATA COLLECTION Data entry will be performed by every participating center. Data will be collected in a standardized database, stored by every participating center, and shared with the group at the time of future studies. Data shared between institutions will be deidentified and whenever possible all measures to conceal patient identifiers and maintain patient confidentiality will be taken.

ETHICS It is the responsibility of the investigator to have prospective approval of the trial protocol, informed consent forms, and other relevant documents, from the IRB/IEC. All correspondence with the IRB/IEC should be retained in the Investigator File.

REtroperitoneal SArcoma Registry: an International Prospective Initiative

REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group

Survival after surgery for primary RPS resection; any disease recurrence, local or distant, will be considered as an event at time of first radiological appearance.

Overall Survival computed from date of surgery

CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection

CCI of distant metastasis computed from date of surgery, and defined as hepatic recurrence and / or extrabdominal recurrent disease

Postsurgical morbidity according to Clavien-Dindo classification

TransAtlantic Retroperitoneal Sarcoma Working Group

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

The prognostic factors were analyzed for pT4bN0M0 colorectal cancer after multivisceral resection

multivisceral resection

The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.

Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (MVR), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. In this study, investigators attempted to evaluate the prognostic factors of pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pT4bN0M0 patients.

Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection

Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection: A Multi-institutional Retrospective Analysis

Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.	NCT04646772	Malignant Neopl...	Multivisceral r...	18 Years -	Santo Spirito Hospital, Italy
Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches	NCT05707598	Colorectal Canc...	Laparoscopic su...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
REtroperitoneal SArcoma Registry: an International Prospective Initiative	NCT03838718	Retroperitoneal...		18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection	NCT06115837	Colorectal Canc...	multivisceral r...	18 Years - 95 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.	NCT04646772	Malignant Neopl...	Multivisceral r...	18 Years -	Santo Spirito Hospital, Italy

Spots Global Cancer Trial Database for multivisceral resection