Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma

NCT ID: NCT03601689

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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rectal resection

total mesorectal excision

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moroccan Society of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Batna anticancer center

Algiers, , Algeria

Site Status

Mohammed V University Medical School, Surgery Department, Military Hospital

Rabat, Please Enter the State Or Province, Morocco

Site Status

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

Rabat, Please Enter the State Or Province, Morocco

Site Status

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

Rabat, Please Enter the State Or Province, Morocco

Site Status

National Institut of Oncology, Surgical oncology department

Rabat, Please Enter the State Or Province, Morocco

Site Status

Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,

Fes, , Morocco

Site Status

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

Oujda, , Morocco

Site Status

Private surgical oncology center

Salé, , Morocco

Site Status

Countries

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Algeria Morocco

References

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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.

Reference Type DERIVED
PMID: 31660903 (View on PubMed)

Other Identifiers

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CompleteResponse

Identifier Type: -

Identifier Source: org_study_id

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