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Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore® in Patients With Non Metastatic Rectal Cancer

RecruitingNAAges 18 Years - anyAllInstitut Sainte Catherine
NCT06536127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 PRODIGE 23 trial evaluated a regimen of FOLFIRINOX chemotherapy prior to neoadjuvant RTCT, with 3-year disease-free survival as the primary endpoint. Patients in the PRODIGE 23 arm had significantly better 3-year disease-free survival (76% versus 69%; p=0.034) and 3-year metastasis-free survival (79% versus 72%; p=0.017) than patients in the standard arm, and the complete histological response rate to neoadjuvant treatment (ypT0N0) doubled from 12% in the standard arm to 28% in the PRODIGE 23 arm. The main benefit of surgical de-escalation is to improve patients' quality of life. The main obstacle to the non-surgical management of these patients with a complete response after RTCT was the i

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📋 Eligibility rules (as published)
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
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What it tests

  • Blood samples
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Where

1 site
ICAP
Avignon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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