Rectal CancerCMRCNCT06839508
Comprehensive Management of Rectal Cancer
An observational study of Rectal Cancer, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
study on the strategy we have adopted for rectal cancer treated with chemoradiotherapy in the case of a complete reponse ( surveillance vs. surgery) Particular Case of Patients with Complete Response After CRT. Read more about this study
- Who is it for?
- Ages 37 to 98 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Radio chemotherapy
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2024to 10 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients
Who may be able to join
- All patients managed in our facility who achieved a complete response after preoperative radio-chemotherapy.
Who cannot join
- Minor patients
- Non-responding patients, or partial responders.
- Anal canal cancer
Trial locations and contacts
1 site in 1 country.
About this study
study on the strategy we have adopted for rectal cancer treated with chemoradiotherapy in the case of a complete reponse ( surveillance vs. surgery) Particular Case of Patients with Complete Response After CRT. Traditionally, for patients with mid or lower rectal cancer, a protocol involving chemoradiotherapy followed by surgery 8 to 10 weeks after the end of radiotherapy and chemotherapy is systematically indicated after a post-chemoradiotherapy reassessment using pelvic MRI.
In a certain number of patients (25%), it was noted that the reevaluation through pelvic MRI after chemoradiotherapy shows complete tumor disappearance.
Read more
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.
- Conditions
- Rectal Cancer
- Being tested
- Radio chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio chemotherapyOther
The task involves identifying similarities in biopsy samples (prior to radio-chemotherapy treatment) to predict a hypothetical complete response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radio chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
results heterogeneous.
In all patients, a reevaluation was performed using a digital rectal exam (DRE), a rectosigmoidoscopy, a pelvic MRI, and a PET scan.
Measured: 10/05/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start20 Apr 2024
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839508
- Sponsor's protocol ID
- 0073_CHIRURGIE
- Acronym
- CMRC
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Management of Rectal Cancer
- ClinicalTrials.gov ID
- NCT06839508
- Acronym / sponsor ID
- CMRC / 0073_CHIRURGIE
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study on the strategy we have adopted for rectal cancer treated with chemoradiotherapy in the case of a complete reponse ( surveillance vs. surgery) Particular Case of Patients with Complete Response After CRT. Traditionally, for patients with mid or lower rectal cancer, a protocol involving chemoradiotherapy followed by surgery 8 to 10 weeks after the end of radiotherapy and chemotherapy is systematically indicated after a post-chemoradiotherapy reassessment using pelvic MRI.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Particular Case of Patients with Complete Response After CRT Traditionally, for patients with mid o | – | Other: Radio chemotherapyAn 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. |
Who may qualify
- Ages
- 37 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients
Key inclusion criteria (1 listed)
- All patients managed in our facility who achieved a complete response after preoperative radio-chemotherapy.
Key exclusion criteria (3 listed)
- Minor patients
- Non-responding patients, or partial responders.
- Anal canal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio chemotherapyThe task involves identifying similarities in biopsy samples (prior to radio-chemotherapy treatment) to predict a hypothetical complete response. | Other | Particular Case of Patients with Complete Response After CRT Traditionally, for patients with mid o |
Primary outcome
results heterogeneous.
Time frame: 10/05/2024
In all patients, a reevaluation was performed using a digital rectal exam (DRE), a rectosigmoidoscopy, a pelvic MRI, and a PET scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- site webLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results heterogeneous. (time frame: 10/05/2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.