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New treatment option for Rectal Cancer
Official title Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore® in Patients With Non Metastatic Rectal Cancer
ClinicalTrials.gov ID: NCT06536127
What this study is testing
- What it's testing
- 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.
- 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 and older
You may be able to join if
- 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...
- IMRT-type radiotherapy treatment
You likely can't join if
- 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/...
- Psychological, social, family or geographical conditions preventing compliance with the study protocol and follow-up examinations.
See the full eligibility 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...
- 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Avignon, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Avignon, 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.