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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COMPLETED
8 participants
OBSERVATIONAL
2024-04-20
2024-05-10
Brief Summary
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In a certain number of patients (25%), it was noted that the reevaluation through pelvic MRI after chemoradiotherapy shows complete tumor disappearance.
However, these patients were still operated on according to the standard procedure, and pathologists found no tumor in the surgical specimen (sterile specimen).
These are patients with a complete radiological and pathological response. In such cases, it is possible to resect the scar that remains at the site of the tumor (radiotherapy sequelae) and closely monitor the patient to detect recurrence in the short and medium term, thus avoiding mutilating surgery that impacts quality of life (fecal and gas incontinence, increased bowel movements, urinary and gynecological sexual disorders). This is known as the "Watch and Wait" strategy.
"Watch and Wait" Strategy. An initial opportunistic approach, also called Watch and Wait (W\&W), involves monitoring patients who are considered to have a complete response after CRT or total neoadjuvant treatment, regardless of the initial stage. This approach was developed by Habr-Gama et al. in Brazil and published in 18 different articles, involving a cohort of 361 patients, with complete response rates ranging from 20% to 30%. Local recurrence rates varied from 5% to 25% depending on the articles and the timing of complete clinical response evaluation, while maintaining a 5-year disease-free survival rate of 52% and an overall survival rate of 85%. These series primarily included cT2 or cT3 tumors, but also cT4 tumors. Complete clinical response was defined as the absence of any clinical tumor residue (no tumor, no ulcer, and negative biopsy), and patients were monitored monthly.
However, the evaluation timeline for complete response varied across the articles, ranging from 8 weeks to 14 months.
At present, no official recommendations validate this strategy; it remains an expert opinion. The aim is to demonstrate that we could avoid surgery in patients with a complete response (we have favored rectal surgery for the majority of our patients due to organizational obstacles, patient-related issues, and the difficulty in applying rigorous surveillance in certain cases).
The purpose of this research is to improve our practices in managing rectal cancer in patients with a complete response.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Particular Case of Patients with Complete Response After CRT Traditionally, for patients with mid o
An initial opportunistic approach, also called Watch and Wait (W\&W), involves monitoring patients who are considered to have a complete response after CRT or total neoadjuvant treatment, regardless of the initial stage. This approach was developed by Habr-Gama et al.
Radio chemotherapy
The task involves identifying similarities in biopsy samples (prior to radio-chemotherapy treatment) to predict a hypothetical complete response.
Interventions
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Radio chemotherapy
The task involves identifying similarities in biopsy samples (prior to radio-chemotherapy treatment) to predict a hypothetical complete response.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-responding patients, or partial responders.
* Anal canal cancer
37 Years
98 Years
ALL
No
Sponsors
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Centre Hospitalier de Saint-Denis
OTHER
Responsible Party
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Locations
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CH Saint Denis
Saint-Denis, , France
Countries
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Related Links
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Other Identifiers
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0073_CHIRURGIE
Identifier Type: -
Identifier Source: org_study_id
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