Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05300789 |
| Other study ID # |
04/21-4398 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
July 15, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Hospital San Carlos, Madrid |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is an observational retrospective cohort study to determine metachronous peritoneal
carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic
exam corresponding to pT4 tumors.
Based on a sample size calculation of 1152 patients, a retrospective review of a three year
period of every participant hospitals, 50 in total, of different characteristics, was
stablished.
Demographic, clinical, operative, histologic and oncologic follow-up variables were recorded.
Description:
This is an observational retrospective cohort study to determine metachronous peritoneal
carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic
exam corresponding to pT4 tumors.
A national multicenter retrospective cohort study is proposed. Given that the objectives of
the study is to establish the prognostic oncologic impact of developing metachronous
peritoneal carcinomatosis, it is intended to include patients who have completed three years
of follow-up, therefore, the period of inclusion of patients to be analyzed is from 2015 to
2017.
Inclusion criteria:
- Patients operated on for colon cancer, considering those patients with neoplasia located
from 15 cm from the anal margin in the proximal direction.
- Patients with histological confirmation of colon adenocarcinoma.
- Postoperative anatomical-pathological staging pT4a and pT4b.
- Patients operated both electively and urgently.
- Patients in whom a complete macroscopic resection of the primary tumor is achieved.
Exclusion criteria:
- Histological types other than adenocarcinoma, such as leiomyosarcomas, GIST,
neuroendocrine tumors and other less frequent forms.
- Patients in whom the persistence of macroscopic oncological disease is described after
the intervention on the primary tumor, considering it totally unresectable.
Definitions:
Definition of peritoneal carcinomatosis: presence of oncological disease at the peritoneal
level, whether single or multifocal, and that is clearly recognizable and distinguishable
from other forms of loco-regional recurrence of colon cancer such as anastomotic, mesenteric
or lymph node recurrence and retroperitoneal form.
Definition of second look type surgery: it is considered all that programmed intervention
carried out to rule out the presence of peritoneal carcinomatosis based on
anatomo-pathological or clinical data related to the primary tumor and its debut form, but
without the existence of clinical, analytical data or radiological during follow-up that
allow it to be suspected.
Variables collected:
- Center code: each participating center will receive an exclusive code that will be the
first variable in the database in order to identify the participation of each center in
the study.
- Patient code: each patient included in each center will receive a consecutive numerical
code to identify the participation of each center in the study.
- Demographic variables: sex, date of birth, body mass index (BMI).
- Patient comorbidity: the comorbidity of the collected patients will be shown exclusively
with the anesthetic risk of the American Association of Anesthesiology (ASA Score).
- Primary neoplasm: diagnosis by presence and type of symptoms or diagnosis in the
asymptomatic phase, location of the tumor and preoperative clinical staging based on
extension studies.
- Operative data: date of the intervention, type of intervention (urgent vs. scheduled),
approach, findings, type of resection performed, primary anastomosis or not, diverting
or terminal stoma and postoperative complications at 30 days, especially those of
infectious origin intra-abdominal. The rest of the complications that arise will be
collected according to the Clavien-Dindo classification but will not be specified.
- Anatomical-pathological data: result of the cytological study if it has been carried
out, histological type of the tumor, degree of differentiation, tumor staging according
to the TNM classification and other histological prognostic criteria such as vascular,
lymphatic and perineural infiltration.
- Adjuvant treatments: it will be collected if the patient underwent adjuvant treatment or
not and if the proposed chemotherapy scheme could be carried out completely or was
interrupted for any reason.
- Follow-up: performance of second look type surgery, findings during it, surgical
technique performed, appearance or not of recurrence and the date of recurrence, type of
recurrence (peritoneal carcinomatosis or distant metastasis), form of diagnosis of
recurrence ( clinical, analytical, radiological or histological confirmation), salvage
surgery for peritoneal carcinomatosis and, if so, rate of peritoneal carcinomatosis and
technique used, performed in the same center or referral of the patient, performed by a
unit specialized in surgery of peritoneal carcinomatosis or not, mortality and whether
this was caused by the terminal evolution of the oncological process and the date of the
last control (date of death or date of the last follow-up of the patient), with which
the disease-free survival and the overall survival.
Calculation of the sample size. To carry out an adequate calculation of the sample size, the
only multicenter prospective study at the national level of patients operated on for colon
cancer, the ANACO study, has been used as a reference. In that study, with 52 participating
centers, during a full year 3230 patients were registered who, after applying different
exclusion criteria, remained in 2968, of which 550 patients were classified as T4 tumors
after the histological study, that is, almost 20% of the tumors operated on in our
environment.
Based on these figures, assuming a degree of participation similar to that obtained in the
ANACO study, establishing an approximate figure of 1,500 pT4a/b colon tumors as the target
population over the three years of study in our country. , an incidence of peritoneal
carcinomatosis of approximately 15%, a confidence level of 95% and a precision of +/- 1
percentage units, a random sample of 1152 individuals is sufficient for the estimate to be
made in this work.
Statistical method A descriptive analysis of demographic and clinical variables will be
performed. Categorical variables will be presented as percentages and frequencies. The
distribution of continuous variables will be evaluated using the Shapiro-Wilk statistic and
they will be described as mean and standard deviation if they follow a normal distribution or
as median and interquartile range (IQR) otherwise.
The association between the variables collected and the objective variables of the study will
be made using Pearson's Chi-square test or Fisher's exact test, as appropriate, in the case
of categorical variables and, for continuous variables, using Student's t-test for
independent samples or Mann-Whitney U, respectively, depending on whether or not their
distribution is adjusted to normal.
Project schedule and phases
- November - December 2020: Preparation and approval of the study protocol by the members
of the Coloproctology Section of the Spanish Association of Surgeons.
- January - February 2020:
- Application for approval by the local ethics committees of the centers of the
members of the Section involved in the project.
- Invitation to participate in the study by means of a formal letter to the
department heads of the centers considered most representative and with the
greatest volume in colon cancer surgery. For this purpose, the registry of
participating centers in the previous ANACO registry has been used.
- Open invitation to all members of the Spanish Association of Surgeons through
official communication by the Section of the start-up of the study.
- Preparation of the database in Excel format for later dissemination among the study
participants.
- March - June 2020:
- Confirmation and commitment by the centers interested in participating in the
study.
- Collection of data and sending of the files to those responsible for the project.
- July September:
- Condensation of the data from the different files into a single file.
- Statistical study and obtaining results.
- October - December 2021:
- Preparation of an original manuscript for submission and assessment for
publication.
