Tailored chemo doses may help seniors fight pancreatic cancer while staying independent
NCT ID NCT02143219
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a chemotherapy cocktail called FOLFIRINOX in 72 patients aged 70 or older with metastatic pancreatic cancer. The doses were adjusted based on each person's genetics to reduce side effects while still fighting the tumor. The goal was to see if this approach could control the cancer and help patients maintain their ability to perform daily activities.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
72 people
The number who actually took part.
- Started
-
Jul 2014
- Finished
-
Nov 2020
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
70 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically proven ductal pancreatic carcinoma * Metastatic disease * First-line treatment : No previous chemotherapy in metastatic stage but adjuvant treatment before relapse (secondary metastatic) is permitted, provide it has been administered more than 6 months before) * Age of 70 yo or above * Normal DPD enzyme level or partial defect (excluding total defect) * Adequate bone marrow reserve: as indicated by : neutrophils \>1500/mm3, platelets \>100,000/ mm3, Hb \>10.0g/dL. * Adequate Renal function as indicated by: MDRD creatinine clearance \> 50ml/min. * Adequate hepatic function as indicated by: serum bilirubin \< 1.5 times the upper limit of normal, AST and ALT \< 2.5 times the upper limit of normal, or \< 5 times the upper limit of normal if liver metastases are present. * Written informed consent must be obtained prior to protocol-specific procedures are being performed * Patient is affiliated to a social security category Exclusion Criteria: * Other than ductal pancreatic carcinoma: namely endocrin tumors, acinar cells carcinoma, cystadenocarcinoma or adenocarcinoma of the ampulla of vater * Non-metastatic but locally advanced pancreatic adenocarcinoma * Complete DPD deficiency * History of Cardiac failure or symptomatic coronary artery disease * Autonomy Daily Living score by Katz \<4 * Prior treatment with FOLFIRINOX (adjuvant) * Major comorbidity likely to be an obstacle to treatment * Active or uncontrolled infection such as HIV or chronic B or C hepatitis * Uncontrolled diabetes mellitus * Prior peripheral neuropathy, grade \> 2 * Inflammatory bowel disease localized on the colon or rectum; bowel obstruction or severe uncontrolled diarrhea * Previous or concomitant malignancies other than effectively treated carcinoma in situ of the cervix or non-melanoma skin cancer * Hereditary fructose intolerance * Persons deprived of liberty or under guardianship * Any social, geographical or psychological condition which would compromise the ability to fully comply with the trial procedures and treatments
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic pancreatic ductal adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CH Vendée
La Roche-sur-Yon, 85925, France
-
Centre Eugène marquis
Rennes, 35042, France
-
Centre Oscar Lambret
Lille, 59020, France
-
ICM (Val d'Aurelle)
Montpellier, 34298, France
-
ICO Paul Papin
Angers, 49000, France
-
ICO René Gauducheau
Saint-Herblain, 44805, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug candidate takes aim at Hard-to-Treat pancreatic cancer
- Can a Two-Drug combo tame Hard-to-Treat pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can an immunotherapy cocktail slow pancreatic cancer? a new trial aims to find out.
- Smart drug delivers chemo directly to pancreatic cancer cells
- Engineered T-Cells take aim at Hard-to-Treat pancreatic cancer