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Tests treatment safety and results for Metastatic Pancreatic Cancer
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
ClinicalTrials.gov ID: NCT05988814
What this study is testing
What is FOLFIRINOX treatment?
FOLFIRINOX treatment is an investigational medicine, being studied as a potential treatment for metastatic pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 (prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and...
You likely can't join if
- Patient with neuroendocrine carcinoma or acinar cell carcinoma
- Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ of the uterine cervix or cutaneous basal cell carcinoma).
- Presence of brain metastasis(es)
- Estimated prognosis \< 3 months
- History of grade 4 toxicity to oxaliplatin, irinotecan or 5FU if history of adjuvant/neoadjuvant chemotherapy
- Sequellar toxicity \> grade 1 if previous adjuvant/neoadjuvant chemotherapy
See the full eligibility criteria
- 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 (prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and recurrence is greater than 12 months) and no history of curative radiotherapy...
- Patient eligible for treatment with FOLFIRINOX (5-FU, Irinotecan, Oxaliplatin and folinic acid) including but not limited to: No active heart disease An ECG with a QT/QTc interval ˂ to 450 ms for men and ˂ to 470 ms for...
- Tumor evaluation (CT scan) performed within 4 weeks (28 days) prior to inclusion with at least one measurable lesion according to RECIST 1.1 criteria
- Patient fit and able to comply with the protocol for the duration of the study, including treatment, visits, scheduled examinations and follow-up.
- Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days)
- Information given and informed consent signed
- Patient affiliated to a social security scheme
- Men and women must have an effective contraceptive method.
- Patient with neuroendocrine carcinoma or acinar cell carcinoma
- Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ of the uterine cervix or cutaneous basal cell carcinoma).
- Presence of brain metastasis(es)
- Estimated prognosis \< 3 months
- History of grade 4 toxicity to oxaliplatin, irinotecan or 5FU if history of adjuvant/neoadjuvant chemotherapy
- Sequellar toxicity \> grade 1 if previous adjuvant/neoadjuvant chemotherapy
- Hypersensitivity to any component of FOLFIRINOX® treatment.
- Current participation or participation within 30 days prior to inclusion in another therapeutic trial with an investigational compound and/or completion of radiotherapy within 10 days prior to the start of treatment
- Evidence of a homozygous or heterozygous DPYD mutation and/or uracilemia \>16ng/mL and/or homozygous UGT1A1 genotype.
- Pregnancy, breastfeeding
- Inability to sign informed consent or to undergo medical monitoring of the trial for geographical, social or psychological reasons including, but not limited to, psychiatric illness compromising comprehension of...
- Patient under guardianship, curatorship or safeguard of justice.
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.