Actively Recruiting
Evaluation of the Link Between Oxaliplatin-Induced Liver and Nerve Toxicities and Blood Levels of HMGB1 in Patients with Resectable Oesogastric and Pancreatic Adenocarcinoma
Led by University Hospital, Clermont-Ferrand · Updated on 2024-10-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Oesogastric and pancreatic adenocarcinomas are cancers with poor prognosis, and pancreatic cancer is expected to become the second leading cause of cancer death by 2030. This research aims to understand the biological processes involved in sinusoidal obstruction syndrome (SOS), a liver condition triggered by oxaliplatin chemotherapy that increases post-operative complications and risks such as chemotherapy-induced peripheral neuropathy (CIPN). The study explores the role of HMGB1, a protein suspected to mediate these toxic effects, to enable better prevention and treatment strategies. Participants will undergo routine laparoscopy and receive oxaliplatin-based chemotherapy (FLOT, FOLFOX, or FOLFIRINOX) before surgery to remove their tumors. Researchers will assess serum HMGB1 levels before and after chemotherapy and at surgery to investigate its correlation with SOS and CIPN development. The study involves measuring additional markers like RAGE and monitoring liver and neurological health throughout treatment. During the study, participants will have blood tests at exploratory laparoscopy, at the first and last chemotherapy cycles before surgery, and at surgery. SOS diagnosis and CIPN evaluation will occur before chemotherapy, after chemotherapy cycles, and following surgery, with follow-up extending up to 10 months. The primary outcome is the serum HMGB1 concentration at laparoscopy and surgery, helping researchers understand its predictive value for liver and nerve toxicities.
CONDITIONS
Brief Title
Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG WHO Performance status of 0 or 1
- Signed and dated informed consent
- Histological diagnosis of oesogastric or pancreatic adenocarcinoma
- Tumors must be resectable
- Ability to undergo laparoscopy
- No peritoneal invasion detected during laparoscopy
- Candidate for perioperative chemotherapy with FLOT or FOLFOX for oesogastric adenocarcinoma, or FOLFIRINOX for pancreatic adenocarcinoma
- Registered in a national health care system (including CMU)
- Ability to speak and understand French
You will not qualify if you...
- Histology other than adenocarcinoma
- Metastatic disease
- Previous treatment with oxaliplatin
- Systemic chemotherapy within 5 years prior to inclusion
- Unstable progressive medical conditions such as liver failure, renal failure with creatinine clearance <30 mL/min, respiratory failure, congestive heart failure, or recent myocardial infarction within 6 months
- Use of curative dose anticoagulants
- Complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng/ml)
- Not operable for the cancer type
- Pregnant or breastfeeding women, or women of childbearing age without a pregnancy test before procedure
- Legal incapacity or under legal protection
- Psychiatric, social, family, or geographical reasons preventing follow-up or compliance
- Discovery of peritoneal invasion during laparoscopic exploration
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 75 days of chemotherapy before surgery (each cycle = 14 days)
Participants receive oxaliplatin-based chemotherapy and have their serum HMGB1 concentrations assessed before and after treatment.
Visits at first (Day 1) and last chemotherapy cycles before surgery, plus surgery visit
Duration - Up to 10 months after last chemotherapy cycle following surgery
Participants are monitored for chemotherapy-induced peripheral neuropathy (CIPN) and sinusoidal obstruction syndrome (SOS) after treatment and surgery, with blood assessments continuing up to 10 months.
Visits at first and last cycles after surgery and periodic assessments up to 10 months
Trial Site Locations
Total: 1 location
1
CHU Estaing de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
Research Team
M
Marine JARY, MD
B
Brigitte GILLET
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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