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New treatment option for Rectal Cancer
Official title Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients
ClinicalTrials.gov ID: NCT06740357
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- BEFORE any neoadjuvant treatment:
- Tumor classified T2T3 (on MRI)
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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)
- \ 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 assigned by chance to the Experimental Group);
- Person affiliated with or benefiting from a social security scheme;
- Free and informed consent signed by the patient.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.