Rectal CancerEVARECNCT06740357
Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients
A study testing Tumor response monitoring program, Standard evaluation of tumor response and Shared decision-making in people with Rectal Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The adoption of total mesorectal excision (TME) has standardized rectal cancer surgery and improved oncological outcomes. In locally advanced rectal cancer, neoadjuvant radio chemotherapy (NACRT) has further improved oncological benefit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Tumor response monitoring program, Standard evaluation of tumor response and Shared decision-making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2024to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 80
- Histologically proven lieberkuhnian adenocarcinoma with MSS status ;
- Patient who has or is due to receive neoadjuvant treatment (4 to 6 courses of (m)FOLFIRINOX or FOLFOX chemotherapy + CAP 50 radiochemotherapy or CAP 50 radiochemotherapy alone);
- BEFORE any neoadjuvant treatment:
- Tumor classified T2T3 (on MRI)
- N0-N1 (≤ 3 positive lymph nodes * or size ≤ 8 mm) (on MRI)
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- * positive node = node size > 5 mm minor axis and/or morphologically suspicious appearance Tumor size ≤4 cm (ON MRI)
- No distant metastasis (M0)_ TAP scan or PET scan
- ≤ 8 cm from anal margin (On MRI) (Clinical examination*)
- if the clinical examination is not possible, then the source data is that of the MRI.
- No invasion of the anal canal and/or sphincters (internal and external) (On MRI)
- Operable patient
- Ability to comply with the protocol and follow-up appointments (repeated assessment consultations and close follow-up if randomized to the Experimental Group);
- Person affiliated with or benefiting from a social security scheme;
- Free and informed consent signed by the patient.
Who cannot join
- Patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment)
- Contraindication to pelvic MRI
- Patients with MSI status undergoing immunotherapy
- Other concomitant cancer or history of cancer within 5 years, with the exception of carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
- Women who are pregnant, likely to become pregnant, or who are breast-feeding;
- Person under guardianship, curatorship or safeguard of justice, or person deprived of liberty.
- Unable to undergo medical follow-up for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Antoine DROUILLARD, 03 80 29 37 50, antoine.drouillard@chu-dijon.fr
About this study
Official title: Implementation of a Tumor Response Assessment Program Integrating Shared Medical Decision Making Into the Organ Preservation Strategy for Rectal Cancer Patients: Phase III Randomized - Multicenter
The adoption of total mesorectal excision (TME) has standardized rectal cancer surgery and improved oncological outcomes. In locally advanced rectal cancer, neoadjuvant radio chemotherapy (NACRT) has further improved oncological benefit. Although these strategies result in good 5-year disease-free survival rates, they are associated with significant morbidity, in particular permanent long-term bowel, urinary and sexual dysfunction. In rectal cancer management, the main objective of organ preservation is to avoid or reduce morbidity and impact on quality of life after rectal resection, without compromising oncological outcomes.
The aim of this project is to evaluate the efficacy of a defined response monitoring program, including a shared decision process, as a strategy for assessing tumor response in locally advanced rectal cancer after neoadjuvant therapy.
This is a national, phase III, randomized, open-label, multicenter clinical trial comparing the tumor response monitoring program with shared decision-making, versus standard tumor response assessment in organ preservation strategies in rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Tumor response monitoring program, Standard evaluation of tumor response, Shared decision-making, Decision-making according to national recommendations, Follow-up
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor response monitoring programOther
three steps of tumor response evaluation (STEP 1 at 2 months, STEP 2 at 4 months, STEP 3 at 6 months after completion of neoadjuvant treatment): STEP 1: digital rectal examination, pelvic MRI, rectoscopy, TAP scan STEP 2: DRE, pelvic MRI, rectoscopy STEP 3: DRE, pelvic MRI, rectoscopy, TAP or PET scan
Standard evaluation of tumor responseOther
Assessment at 2 months (+/- 7 days) after neoadjuvant treatment: digital rectal exam, pelvic MRI, rectoscopy, TAP scan
Shared decision-makingOther
At each stage of the monitoring program and depending on the clinical and oncological results, the decision to preserve the rectum will be discussed with the patient according to a shared-decision program.
Decision-making according to national recommendationsOther
The decision to preserve the rectum is based on assessment at 2 months after completion of neoadjuvant treatment (standard of care since the GRECCAR2 trial).
Follow-upOther
Every 3 months for 2 years, then every 6 months for the third year
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tumor response monitoring program with shared decision-making | Experimental | Not described Receives: Other: Tumor response monitoring program; Other: Shared decision-making; Other: Follow-up |
| Control: Standard assessment of tumor response (validated in the GRECCAR 2 trial - Lancet 2017) | Active comparator | Not described Receives: Other: Standard evaluation of tumor response; Other: Decision-making according to national recommendations; Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ preservation rate
An organ-preserving patient is defined as a patient who has not undergone rectal resection.
Measured: 2 years after the start of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Dec 2024
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740357
- Sponsor's protocol ID
- DROUILLARD PHRCK 2023-2
- Acronym
- EVAREC
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Tumor Response Assessment Program Integrating Shared Medical Decision Making Into the Organ Preservation Strategy for Rectal Cancer Patients: Phase III Randomized - Multicenter
- ClinicalTrials.gov ID
- NCT06740357
- Acronym / sponsor ID
- EVAREC / DROUILLARD PHRCK 2023-2
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 18 Dec 2024 (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.
The adoption of total mesorectal excision (TME) has standardized rectal cancer surgery and improved oncological outcomes. In locally advanced rectal cancer, neoadjuvant radio chemotherapy (NACRT) has further improved oncological benefit. Although these strategies result in good 5-year disease-free survival rates, they are associated with significant morbidity, in particular permanent long-term bowel, urinary and sexual dysfunction. In rectal cancer management, the main objective of organ preservation is to avoid or reduce morbidity and impact on quality of life after rectal resection, without compromising oncological outcomes.
The aim of this project is to evaluate the efficacy of a defined response monitoring program, including a shared decision process, as a strategy for assessing tumor response in locally advanced rectal cancer after neoadjuvant therapy.
This is a national, phase III, randomized, open-label, multicenter clinical trial comparing the tumor response monitoring program with shared decision-making, versus standard tumor response assessment in organ preservation strategies in rectal cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tumor response monitoring program with shared decision-making | Experimental | Other: Tumor response monitoring program, Other: Shared decision-making, Other: Follow-up |
| Control: Standard assessment of tumor response (validated in the GRECCAR 2 trial - Lancet 2017) | Active comparator | Other: Standard evaluation of tumor response, Other: Decision-making according to national recommendations, Other: Follow-up |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient aged 18 to 80
- Histologically proven lieberkuhnian adenocarcinoma with MSS status ;
- Patient who has or is due to receive neoadjuvant treatment (4 to 6 courses of (m)FOLFIRINOX or FOLFOX chemotherapy + CAP 50 radiochemotherapy or CAP 50 radiochemotherapy alone);
- BEFORE any neoadjuvant treatment:
- if the clinical examination is not possible, then the source data is that of the MRI.
Key exclusion criteria (7 listed)
- Patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment)
- Contraindication to pelvic MRI
- Patients with MSI status undergoing immunotherapy
- Other concomitant cancer or history of cancer within 5 years, with the exception of carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
- Women who are pregnant, likely to become pregnant, or who are breast-feeding;
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 |
|---|---|---|
| Tumor response monitoring programthree steps of tumor response evaluation (STEP 1 at 2 months, STEP 2 at 4 months, STEP 3 at 6 months after completion of neoadjuvant treatment): STEP 1: digital rectal examination, pelvic MRI, rectoscopy, TAP scan STEP 2: DRE, pelvic MRI, rectoscopy STEP 3: DRE, pelvic MRI, rectoscopy, TAP or PET scan | Other | Experimental: Tumor response monitoring program with shared decision-making |
| Standard evaluation of tumor responseAssessment at 2 months (+/- 7 days) after neoadjuvant treatment: digital rectal exam, pelvic MRI, rectoscopy, TAP scan | Other | Control: Standard assessment of tumor response (validated in the GRECCAR 2 trial - Lancet 2017) |
| Shared decision-makingAt each stage of the monitoring program and depending on the clinical and oncological results, the decision to preserve the rectum will be discussed with the patient according to a shared-decision program. | Other | Experimental: Tumor response monitoring program with shared decision-making |
| Decision-making according to national recommendationsThe decision to preserve the rectum is based on assessment at 2 months after completion of neoadjuvant treatment (standard of care since the GRECCAR2 trial). | Other | Control: Standard assessment of tumor response (validated in the GRECCAR 2 trial - Lancet 2017) |
| Follow-upEvery 3 months for 2 years, then every 6 months for the third year | Other | Control: Standard assessment of tumor response (validated in the GRECCAR 2 trial - Lancet 2017), Experimental: Tumor response monitoring program with shared decision-making |
Primary outcome
Organ preservation rate
Time frame: 2 years after the start of neoadjuvant treatment
An organ-preserving patient is defined as a patient who has not undergone rectal resection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor response monitoring program, Standard evaluation of tumor response and Shared decision-making in people with Rectal Cancer, run by Centre Hospitalier Universitaire Dijon 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 15 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quentin DENOST (05 47 50 15 75, q.denost@bordeaux-colorectal-institute.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ preservation rate (time frame: 2 years after the start of neoadjuvant treatment). 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 9 Apr 2025.