Actively Recruiting
Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy
Led by Centre Georges Francois Leclerc · Updated on 2024-02-12
90
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.
CONDITIONS
Official Title
Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age > 18 years at time of study entry
- Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
- Patients with pancreatic adenocarcinoma
- Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic cancer
- Patients with no history of chemotherapy for metastatic or locally advanced disease (prior adjuvant or neoadjuvant chemotherapy allowed if recurrence occurred more than 12 months after treatment)
- No history of curative radiotherapy for metastatic or locally advanced disease (palliative radiotherapy allowed)
- Eligible for FOLFIRINOX treatment including no active heart disease, ECG QT/QTc interval ≤ 450 ms for men and ≤ 470 ms for women, no uncontrolled hypertension despite treatment
- Negative pregnancy test if applicable
- Tumor evaluation by CT scan within 4 weeks prior to inclusion showing at least one measurable lesion per RECIST 1.1
- Able to comply with study protocol, including treatment, visits, exams, and follow-up
- Biological, hepatic, renal, and serological tests within specified limits prior to inclusion
- Provided informed consent
- Affiliated to a social security scheme
- Men and women must use effective contraception
You will not qualify if you...
- Neuroendocrine carcinoma or acinar cell carcinoma
- Other cancers within 5 years prior to inclusion or simultaneously (except uterine cervix in situ or basal cell carcinoma)
- Presence of brain metastases
- Estimated prognosis less than 3 months
- History of grade 4 toxicity to oxaliplatin, irinotecan, or 5-FU if prior adjuvant/neoadjuvant chemotherapy
- Sequelae toxicity greater than grade 1 if prior adjuvant/neoadjuvant chemotherapy
- Hypersensitivity to any component of FOLFIRINOX treatment
- Current or recent participation in another therapeutic trial within 30 days or recent radiotherapy completion within 10 days
- Presence of homozygous or heterozygous DPYD mutation, uracilemia >16ng/mL, or homozygous UGT1A1 genotype
- Pregnancy or breastfeeding
- Inability to sign informed consent or comply with study monitoring due to geographical, social, or psychological reasons
- Under guardianship, curatorship, or legal protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Georges-François Leclerc
Dijon, France, 21000
Actively Recruiting
Research Team
J
Jean-David FUMET, Dr
CONTACT
S
Sophie PARNALLAND, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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