Evaluating the effects of oxaliplatin on liver and nerve toxicity in cancer patients

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 investigates the relationship between hepatotoxicity and neurotoxicity caused by oxaliplatin in patients with resectable pancreatic and esophageal cancers. It aims to assess serum levels of HMGB1 before and after oxaliplatin-based chemotherapy to understand its role in sinusoidal obstruction syndrome (SOS), a common complication that can worsen patient outcomes. By identifying the biological processes involved, the study seeks to optimize chemotherapy administration without compromising patient safety. The research is crucial given the rising incidence of these cancers and the need for effective preoperative treatment strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ECOG WHO Performance status = 0 or 1
* Signed and dated informed consent
* Patients with histological diagnosis of oesogastric or pancreatic adenocarcinoma
* Resectable tumors
* Patients able to have a laparoscopy
* In case of absence of peritoneal invasion on the laparoscopy, patient candidate to a chemotherapy schedule by FLOT or FOLFOX in perioperative setting for oesogastric adenocarcinoma, or FOLFIRINOX in perioperative setting for pancreatic adenocarcinoma
* Registration in a national health care system (CMU included)
* Patient speak and understand the french

Exclusion Criteria:

* Histology other than adenocarcinoma
* Metastatic disease
* History of previous treatment with oxaliplatine
* History of systemic chemotherapy administration within 5 years prior to inclusion,
* Patient with an non balanced progressive condition/disease (liver failure, renal failure (creatinine clearance \<30mL/min), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months, etc.),
* Patient on curative dose anticoagulant,
* Patient with complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng/ml),
* Patient not operable for the pathology concerned,
* Pregnant or breastfeeding woman, woman of childbearing age who has not performed a pregnancy test before the procedure,
* Patient with legal incapacity (person deprived of liberty or under curatorship, stutorship, safeguard of justice),
* Patient who, for psychiatric, social, family or geographical reasons, cannot be followed and/or comply with the requirements of the study,,
* Discovery of peritoneal invasion during the peritoneal exploratory of the laparoscopy

Where it's running

• CHU Estaing de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: Marine JARY, MD — CHU Estaing de Clermont Ferrand/FRANCE
• Study coordinator: Marine JARY, MD
• Email: mjary@chu-clermontferrand.fr
• Phone: +33 4 73 75 05 08

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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.