NCT06649474Recruiting
Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1
Source: ClinicalTrials.gov · Last updated 18 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Oesogastric and pancreatic adenocarcinomas are poor-prognosis cancers. Incidence of pancreatic cancer drastically increases to such an extent that it will become the second cause of cancer's mortality by 2030. A major challenge is to optimize the therapies for localized setting, when oxaliplatin-based chemotherapy is the standard, before and after surgical excision. Because in 50% of cases oxaliplatin triggers a grade 2-3 sinusoidal obstruction syndrome (SOS) which increases post-operative morbidity, decreases histological response to chemotherapy, increases tumor recurrence, and aggravates the risk of chemotherapy-induced peripheral neuropathy (CIPN). There is an urgent need to better understand the biological processes involved in SOS, in order to prevent and treat it without stopping or reducing oxaliplatin administration. The biological link between oxaliplatin and SOS has not been described, but recent murine experiments argue for HMGB1 to be the mediator released after exposure to oxaliplatin and inducing SOS, and thereafter CIPN. To date, no biomarker is established between murine and patient analyses, and the release of HMGB1 after oxaliplatin treatment and its effect on hepatic parenchyma is not described in patients. Investigators hypothesized is that HMGB1 would also been increased in patients after oxaliplatin treatment, and correlated to the development of SOS and CIPN. If confirmed, personalized treatment will be possible to target this pathway. Therefore, investigators propose to dynamically explore this hypothesis in localized oesogastric and pancreatic cancer patients who will be routinely managed by an initial laparoscopy and post-oxaliplatin surgical excision.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Sept 2024
- Start date
- 6 Sept 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- University Hospital, Clermont-Ferrand
- NCT number
- NCT06649474
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 6 Sept 2024 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous treatment with oxaliplatine
- History of systemic chemotherapy administration within 5 years prior to inclusion,
Other illness
- Metastatic disease
- Patient who, for psychiatric, social, family or geographical reasons, cannot be followed and/or comply with the requirements of the study,,
Lab values
- 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.),
Age
- Pregnant or breastfeeding woman, woman of childbearing age who has not performed a pregnancy test before the procedure,
Other
- Histology other than adenocarcinoma
- Patient on curative dose anticoagulant,
- Patient with complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng/ml),
- Patient not operable for the pathology concerned,
- Patient with legal incapacity (person deprived of liberty or under curatorship, stutorship, safeguard of justice),
- Discovery of peritoneal invasion during the peritoneal exploratory of the laparoscopy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Estaing de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.