NCT03601689

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

9 years

First QC Date

July 14, 2018

Last Update Submit

July 24, 2018

Conditions

Rectal Neoplasms

Keywords

Low rectal cancerNeoadjuvant treatmentComplete pathological responseypT0N0disease free survivalPredictive factors

Outcome Measures

Primary Outcomes (2)

  • Local recurrence rate

    A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.

    From date of surgery until the date of first documented local progression assessed up to 100 months

  • Distant recurrence rate

    A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.

    From date of surgery until the date of first documented distant progression assessed up to 100 months

Secondary Outcomes (1)

  • Predictive factors of disease free survival

    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

Interventions

rectal resectionPROCEDURE

total mesorectal excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients who underwent neoadjuvant treatment followed by total mesorectal excision for rectal adenocarcinoma in 8 centers

You may qualify if:

  • 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

You may not qualify if:

  • \- all patients with metastatic tumors or missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Batna anticancer center

Algiers, Algeria

Location

Mohammed V University Medical School, Surgery Department, Military Hospital

Rabat, Please Enter the State Or Province, 10001, Morocco

Location

Mohammed V University Medical School, Surgical Department "A", Ibn Sina Hospital

Rabat, Please Enter the State Or Province, 10001, Morocco

Location

Mohammed V University Medical School, Surgical Department "C", Ibn Sina Hospital,

Rabat, Please Enter the State Or Province, 10001, Morocco

Location

National Institut of Oncology, Surgical oncology department

Rabat, Please Enter the State Or Province, 10001, Morocco

Location

Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,

Fes, Morocco

Location

Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi

Oujda, Morocco

Location

Private surgical oncology center

Salé, Morocco

Location

Related Publications (1)

  • 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.

    PMID: 31660903DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsPathologic Complete Response

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2018

First Posted

July 26, 2018

Study Start

January 1, 2005

Primary Completion

December 31, 2013

Study Completion

March 31, 2016

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

AL(1)MO(7)