Instructions for completing the CRFs are set out below.
Each CRF is a fillable pdf file. At the bottom of the last page of each CRF there are four buttons with their respective functions: print, send, save and reset. Each CRF must be completed in the header with the patient’s initials, the date of birth, the number provided for the randomization and the date of randomization and signed by the doctor who fills it in by inserting the initials in the appropriate form.
Sending the CRF
All CRFs must be sent by email, after having duly completed them, using the specific button present in each CRF. Specify the patient code and the type of CRF in the subject of the email. All CRF modules have already set the email address to send the CRF to.
To compile the CRF it is necessary to open the files with Acrobat Reader, which can be downloaded free of charge here .
Using Acrobat Reader it is possible to compile, send, print and save the CRFs locally directly online from the browser used.
1 – CRF of randomization
The Participating Centers must complete it in its first part, reporting the initials, the date of birth, the age, height and weight of the patient and the type of planned intervention and radiotherapy, at the time of the patient’s enrollment and send it to the Coordinating Center. , via email to the address already set in the form.
The second part will be filled in with the indication of the timing to be followed by the Data Managers of the Coordinating Center, who will send the CRF with the randomization data to the reference email address indicated by the Head of the Study of the Participating Center.
2 – CRF Clinical Information (Anamnesis)
This CRF is structured in such a way as to retrieve the main information on any patient comorbidities that may affect the treatment, and on the main symptoms that led to the diagnosis. Briefly indicate the main ongoing chronic therapies of the patient.
3 – CRF Endoscopy
In this CRF, the completeness of the examination and the location of the tumor must be indicated, with the distance from the anal margin.
4 – CRF CT Scan
Information on the state of the disease must be reported in this CRF. Please note that in the presence of widespread disease, the patient will be excluded from the study. Also indicate whether the examination is part of the initial staging (neoadjuvant pre-treatment) or re-staging (neoadjuvant post-treatment).
5 – CRF MRI
Information on the state of the disease must be reported in this CRF. Indicate the type of examination (liver or pelvic MRI). Please note that in the presence of widespread disease, the patient will be excluded from the study. Also indicate whether the examination is part of the initial staging (neoadjuvant pre-treatment) or re-staging (neoadjuvant post-treatment). The MRI report must be accompanied by the structured report present in the Documentation section as per ESMO 2016 and ESGAR guidelines, reported in the Trial protocol in section 5.4 MRI.
Note on the Structured Report
Description of the ymrT and ymrTRG
ymrT it is based on the interpretation of the extent of the persistent tumor signal related to the layers of the rectum wall. Tumor response is evaluated as tumor signal substitution with low signal strength or fibrosis (dark stroma) or the development of high signal strength mucin pools, which are not considered tumor tissue.
ymrTRG it is based on principles similar to the ypTRG pathological system described by Dworak and subsequently modified by Mandard.
6 – CRF Neoadjuvant
This CRF must report the start of treatment (RT and CHT) and their type and their possible interruption, including any changes in the treatment strategy. In case of interruption of treatment or modification of strategy that involves the use of RT alone, the patient will be excluded from the trial and the CRF Exclusion (only in case of treatment interruption) and the CRF Neoadjuvant exclusion must be completed. It is mandatory to report the beginning and the end of the treatment with timely communication to the Coordinating Center which will record the dates for checking the surgical timing previously indicated on the basis of randomization.
7 – CRF Operative
Indicate the surgical procedures and techniques actually performed, the duration of the total intervention and the specific techniques indicated. Also enter any intraoperative complications and any ostomy packaging.
7 – CRF Pathology Report
Fill in each part as requested in the form. Forms for compiling the pathological report other than the one indicated are not accepted. The regression indices sec. Dworak and sec. Mandard. (See section Documentation )
8 – Postoperative CRF
Indicate one or more complications that may have occurred and the degree according to the Clavien-Dindo classification. Report the patient’s status and any reoperation with motivation.
CRF 30-day Postoperative
As for the previous CRF, indicate one or more complications that may have occurred, the status of the patient and any reoperation with motivation.
9 – CRF Follow UP
Report the information requested according to the schedule indicated in the synopsis and in the study protocol. Report the follow up date.
10 – CRF Death Report
Report the causes of death and any correlation with the pathology studied in the Trial.
11 – CRF Neoadjuvant Exclusion
Fill in the form only in case of interruption of the neoadjuvant treatment due to toxicity developed by the patient such as not to allow the continuation of the treatment and send it promptly to the data managers of the Coordinating Center.
12 – CRF Exclusion
Fill in according to the choices described in the sheet. In case of discontinuation of neoadjuvant treatment, also associate the CRF Neoadjuvant Exclusion. Promptly send the CRF to the data managers of the Coordinating Center.
Questionnaires should be printed and submitted to patients according to the following timeline:
- At randomization (excluding LARS, WEXNER)
- after neoadjuvant treatment, before surgery (excluding LARS, WEXNER)
- 30 days after surgery
- 6 months after surgery
- 12 months after surgery
- 24 months after surgery
- 36 months after surgery
- 48 months after surgery
- 60 months after surgery
NB : In ostomised patients, the WEXNER and LARS must be delivered one month after recanalization.
Subsequently they must be sent by email to the following address: CRF_timisnar@ospedale.al.it