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

NCT ID: NCT05988814

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-24
• Study Completion Date: 2029-07-24

Brief Summary

Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.

Detailed Description

Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.

Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRINOX treatment

Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.

Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.

Group Type: EXPERIMENTAL

FOLFIRINOX treatment

Intervention Type: DRUG

Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.

Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression

Interventions

FOLFIRINOX treatment

Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses.

Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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 for metastatic or locally advanced disease. Palliative radiotherapy is accepted.
• 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 women. No uncontrolled hypertension defined by systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. A negative pregnancy test if applicable
• 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.

Exclusion Criteria

• 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 information or conduct of the study.
• Patient under guardianship, curatorship or safeguard of justice.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Georges-François Leclerc

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-David FUMET, Dr

Role: CONTACT

jdfumet@cgfl.fr

380737538 ext. +33

Sophie PARNALLAND, Project manager

Role: CONTACT

sparnalland@cgfl.fr

345348077 ext. +33

Facility Contacts

Fumet Jean David, Dr

Role: primary

jdfumet@cgfl.fr

03 80 73 75 00 ext. +33

Sophie Parnalland

Role: backup

sparnalland@cgfl.fr

03 45 34 80 77 ext. +33

Other Identifiers

2023-505889-29-00

Identifier Type: -

Identifier Source: org_study_id