Status:
ACTIVE_NOT_RECRUITING
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Rectal Cancer
Liquid Biopsy
Eligibility:
All Genders
18+ years
Brief Summary
Routine clinical and radiological assessment of response of patients with rectum cancer to neoadjuvant chemoradiotherapy does not allow accurate identification of complete pathological response, and l...
Detailed Description
Neoadjuvant treatment (NT) followed by total mesorectum excision (TME) constitues the gold standard for locally advanced carcinoma of the low and middle rectum. When good clinical response to NT is ob...
Eligibility Criteria
Inclusion
- Adenocarcinoma of rectum histologically proven
- Location ≤ 10 cm from the anal margin
- Stage T3T4, or T2 if low rectal cancer
- With indication of radiochemotherapy alone or chemotherapy followed by chemoradiotherapy prior to total mesorectal surgery or transanal surgery
- No metastasis
- Operable patient
- Patient ≥ 18 years old
- Patient likely to receive radiation therapy and chemotherapy.
- No history of pelvic radiotherapy for any reason
- No history of chemotherapy unless it was more than 10 years ago
- Effective contraception for patients of childbearing age: male and non-menopausal women must agree to use two medically validated methods of contraception (one for the patient and the other for the partner) during treatment and less up to 6 months for men and 4 months for women after last treatment
- Patient information and obtaining free, informed and written consent, signed by the patient and his investigator.
- Affiliate subject or beneficiary of a social security scheme of a member country of the European Community (article L1121-11 of the Code of Public Health)
Exclusion
- Tumor of the upper rectum (\> 10 cm from the anal margin)
- Metastatic disease
- . T1 stage tumor
- History of pelvic radiotherapy and chemotherapy
- Contraindication to chemotherapy and / or radiotherapy
- . Insufficient tumoral sample on initial rectal biopsy for performing molecular analysis of tumor by NGS.
- Other concomitant cancer or history of cancer other than treated in situ cervix cancer or basal cell or squamous cell carcinoma
- Pregnant woman, likely to be pregnant or breastfeeding
- Symptomatic cardiac and / or coronary insufficiency
- Severe renal impairment (creatinine clearance less than 30ml / min)
- Full or partial deficiency in dihydropyrimidine dehydrogenase (DPD) (uracilemia ≥ 16 ng / ml)
- Peripheral neuropathy\> grade 1
- Treatment with St. John's Wort
- Treatment with yellow fever vaccine
- Treatment with prophylactic phenytoin
- Treatment with sorivudine or its chemically analogues related, such as brivudine
- Active infection or other serious underlying disease likely to prevent the patient from receiving treatment
- Persons deprived of their liberty, or under measure of judicial protection (curatorship or guardianship) or incapable of giving their consent
- Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons.
Key Trial Info
Start Date :
September 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04852653
Start Date
September 21 2021
End Date
March 1 2026
Last Update
July 30 2025
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France