Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
NCT ID: NCT04095468
Last Updated: 2019-09-19
Study Results
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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RECRUITING
215 participants
OBSERVATIONAL
2017-09-18
2026-01-01
Brief Summary
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This is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Resectable rectal cancer
Preoperative Radio(Chemo)Therapy
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
Rectal cancer with threatened mesorectal fascia
Preoperative Radio(Chemo)Therapy
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
Interventions
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Preoperative Radio(Chemo)Therapy
Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
Eligibility Criteria
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Inclusion Criteria
* Low tumour (accessible by digital rectal examination)
* Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.
* Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR
Exclusion Criteria
* Cancers situated in the upper rectum
* Distant metastases
18 Years
ALL
No
Sponsors
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Polish Society of Surgical Oncology
UNKNOWN
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Responsible Party
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Locations
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Maria Skłodowska-Curie Institute - Oncology Center
Warsaw, Mazovian, Poland
Collegium Medicum Nicolaus Copernicus University and Oncology Centre
Bydgoszcz, , Poland
Regional Oncological Centre
Kielce, , Poland
Jagiellonian Medical University College
Krakow, , Poland
St. John's Cancer Center
Lublin, , Poland
Silesian Oncological Centre
Wroclaw, , Poland
NU-MED Centre for Cancer Diagnosis and Treatment
Zamość, , Poland
Countries
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Central Contacts
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Facility Contacts
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Michał Jankowski, M.D.
Role: primary
Jacek Sadowski, M.D.
Role: primary
Piotr Richter, M.D.
Role: primary
Małgorzata Jankiewicz, M.D.
Role: primary
Jolanta Szelachowska, M.D.
Role: primary
Marek Mazurek, M.D.
Role: primary
Other Identifiers
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ORGANPRESERV1
Identifier Type: -
Identifier Source: org_study_id
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