Evaluating the effects of oxaliplatin on liver and nerve toxicity in cancer patients
Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1
This study is testing how the cancer drug oxaliplatin affects the liver and nerves in patients with pancreatic and esophageal cancers to help make chemotherapy safer and more effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06649474 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with resectable adenocarcinomas of the pancreas or esophagus who are able to undergo laparoscopy and are scheduled for oxaliplatin-based chemotherapy.
Not a fit: Patients with metastatic disease or those who have previously received oxaliplatin or systemic chemotherapy within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of chemotherapy-related side effects, enhancing patient outcomes in those undergoing treatment for pancreatic and esophageal cancers.
How similar studies have performed: While the specific biological link between oxaliplatin and SOS has not been extensively studied in humans, related murine studies suggest a potential pathway that warrants further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Clermont-Ferrand
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.