Evaluating immune cell characteristics in patients with non-metastatic rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on assessing the phenotype of circulating natural killer (NK) cells and the ImmunoScore® in patients diagnosed with non-metastatic rectal cancer. Participants will undergo standardized chemoradiotherapy treatment, and blood samples will be collected to analyze immune responses. The study aims to understand the relationship between immune cell characteristics and treatment outcomes, potentially guiding future therapeutic strategies. By evaluating these immune parameters, the research seeks to improve patient management and treatment efficacy.

Why it matters

Who can join: the full rules

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

Where it's running

• Icap
  Avignon, France Recruiting

Study contacts

• Study coordinator: Léa Retournard, MDV
• Email: l.retournard@isc84.org
• Phone: +33490276241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.