Clinical trial NCT03601689: Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
Official title: Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Keywords: Low rectal cancer
Neoadjuvant treatment
Complete pathological response
ypT0N0
disease free survival
Predictive factors
Lead sponsor: Moroccan Society of Surgery
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent neoadjuvant treatment followed by total mesorectal excision for rectal adenocarcinoma in 8 centers

Brief summary: Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.


Eligibility criteria: Inclusion Criteria

* patients with a histologically proven low rectal adenocarcinoma,
* no previous or synchronous colorectal disease,
* UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy,
* followed by total mesorectal excision (TME), and
* a complete pathological response defined as ypT0N0

Exclusion Criteria:

- all patients with metastatic tumors or missing data

Primary outcomes:
measure: Local recurrence rate
timeFrame: From date of surgery until the date of first documented local progression assessed up to 100 months
measure: Distant recurrence rate
timeFrame: From date of surgery until the date of first documented distant progression assessed up to 100 months
Secondary outcomes:
measure: Predictive factors of disease free survival
timeFrame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Batna anticancer center
city: Rabat
country: Morocco
facility: Mohammed V University Medical School, Surgery Department, Military Hospital
state: Please Enter The State Or Province
city: Rabat
country: Morocco
facility: Mohammed V University Medical School, Surgical Department "A", Ibn Sina Hospital
state: Please Enter The State Or Province
city: Rabat
country: Morocco
facility: Mohammed V University Medical School, Surgical Department "C", Ibn Sina Hospital,
state: Please Enter The State Or Province
city: Rabat
country: Morocco
facility: National Institut of Oncology, Surgical oncology department
state: Please Enter The State Or Province
city: Fès
country: Morocco
facility: Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,
city: Oujda
country: Morocco
facility: Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi
city: Salé
country: Morocco
facility: Private surgical oncology center
Study officials:
References:
citation: Souadka A, Majbar MA, Benkabbou A, Serji B, Souiki T, Bouchentouf SM, Abid M, El Khannousi B, El Harroudi T, El Malki HO, Raiss M, Ifrine L, Mazaz K, Zentar A, Mohsine R, Souadka A, Belkouchi A, Ahallat M, Hrora A; Moroccan Society of Surgery. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series. BMC Cancer. 2019 Oct 28;19(1):1008. doi: 10.1186/s12885-019-6239-3.