Status:
RECRUITING
Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore® in Patients With Non Metastatic Rectal Cancer
Lead Sponsor:
Institut Sainte Catherine
Conditions:
Rectal Cancer
Non Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Until 2020, the standard treatment for rectal cancer was a combination of radiotherapy and concomitant chemotherapy based on IV or oral 5FU, with a low complete response rate. The randomised phase 3 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥ 18 years
- Histologically proven adenocarcinoma of the rectum
- Patient with rectal cancer (cT2-4N0 or cT1-T4N+)
- Patients whose planned treatment is: standardised CTRT comprising 50Gy intensity-modulated irradiation and Capecitabine with or without additional dose (contact therapy). Neoadjuvant chemotherapy with FOLFOX or FOLFIRINOX may be given prior to RTCT.
- IMRT-type radiotherapy treatment
- Women of childbearing age must provide proof of effective contraception (sterilisation for you and/or your partner, transdermal, vaginal, oral, subcutaneous or injectable hormonal contraception and intrauterine devices).
- Person affiliated to or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- Exclusion criteria:
- Metastatic disease
- Unresectable disease
- History of pelvic irradiation or contraindication to pelvic irradiation
- Contraindications to the administration of one of the following chemotherapy drugs: irinotecan, oxaliplatin, or 5 FU, capecitabine
- Presence of an evolving concomitant neoplasia other than the following: i/ treated in situ cervical cancer, ii/ spino or basal cell skin cancer, iii/ cancer in complete remission for more than 3 years.
- Psychological, social, family or geographical conditions preventing compliance with the study protocol and follow-up examinations.
- Persons under legal protection (guardianship, curatorship, safeguard of justice)
- Persons deprived of their liberty
Exclusion
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06536127
Start Date
July 16 2024
End Date
July 30 2028
Last Update
August 2 2024
Active Locations (1)
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1
ICAP
Avignon, France