Neoplasms

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Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

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Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

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Cola

Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center.

Arm B (control): chemotherapy alone, regimen according to each center

Colonic cancer resection, R0 No surgical intervention on metastasis

Colonic resection

Chemotherapy, specified in each center with or without biological drugs

Chemotherapy- scheme

Sebastiano Biondo, Sponsor

Javier Vaqué

Juan García Armengol

Laura Mora

Ignasi Camps Ausàs

Miguel Pera Román

Eduardo Targarona Soler

Lorenzo Viso Pons

José Manuel Ramírez Rodríguez

David Julià Bergkvist

Teresa García Martínez

Mario Álvarez Gallego

José María Enríquez Navascués

Fernando de la Portilla de Juan

Miguel Angel Ciga

Eloy Espín Basany

Manuel Ferrer Márquez

Jesús Abrisqueta Carrión

José Errasti Alustiza

Alberto Parajó Calvo

Carlos Moreno Sanz

Alejando Espí Macías

Ricard Frago Montanuy

Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors.

Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy.

Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).

Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%.

Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically

Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases

Multicenter Randomized Study in Patients With Colorectal Cancer With Unresectable Metastases. Impact of Resection vs no Resection of the Primary Tumour as a Survival Factor

The percentage of patients who are still alive for follow-up at 2 years after randomization.

Postoperative complications were classified according to the Dindo-Clavien classification.

Mortality within 30 days after surgery

The toxicity will be evaluated and documented according to the CTCAE version 4.0.

Identify factors that may influence patient survival before applying any treatment (demographics, clinicals and analitycal factors, tumor characteristics; ...)

Instituto de Salud Carlos III

Hospital Universitari de Bellvitge

Phd, MD

Recurrence

Disease Attributes

Patients aged 18 years or above with pT1 or pT2 N0 colon cancer (up to the recto-sigmoid junction) who underwent curative resection between January 2010 and December 2019

Elective or urgent colonic resection; minimally-invasive or open surgery; completion surgery for endoscopically resected pT1 colon cancer with high risk features

Corrado Pedrazzani, MD

Elisa Corrado

Nicola De Angelis

Michele Simone

Donato Francesco Altomare

Riccardo Nascimbeni

Luigi Zorcolo

Ciarleglio Francesco

Gabriele Anania

Isacco Montroni

Marco Braga

Marco Milone

Delrio Paolo

Maurizio Degiuli

Salvatore Pucciarelli

Andrea Muratore

Claudio Coco

Giuseppe Sica

Roberto Persiani

Maurizio De Luca

Antonino Spinelli

Mauro Santarelli

Alberto Di Leo

Nicolò de Manzini

Mario Trompetto

Corrado Pedrazzani

Patients with stage I (pT1-2 N0 M0) colon cancer (CC) accounts for 15-20% of colonic neoplasia. Stage I CC is mostly cured with surgical resection, consequently, adjuvant chemotherapy is never considered for this subset of patients. Moreover, some international guidelines, including NCCN guidelines, recommend less intensive follow-up 1. However, around 5% of patients with stage I CC will develop a recurrence within 5 years from surgery. Despite the very good prognosis usually attributed to this stage (5-years relapse-free survival: 95%), some clinical and pathological factors beyond the standard AJCC staging may be associated with worse clinical features and may aid in prognostic stratification. Although some authors investigated the role of pathological and clinical factors in patients with stage II and III disease, only few data are available for patients with stage I CC1.

The present multicentric retrospective study aims to:

1. Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.
2. Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.
3. Analyze the pattern of recurrence.
4. Analyze survival after recurrence.

Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer

Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)

Number of patients who relapsed after curative resection

Percentage of patients alive 5 years after surgery

Percentage of patients who did not die from cancer-related causes

Azienda Ospedaliera Universitaria Integrata Verona

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases	NCT02015923	Colonic Cancer Unresectable Me...	Colonic resecti... Chemotherapy- s...	18 Years -	Hospital Universitari de Bellvitge
Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer	NCT05726188	Colon Cancer St... Colon Cancer	Colonic resecti...	18 Years -	Azienda Ospedaliera Universitaria Integrata Verona

Spots Global Cancer Trial Database for colonic resection