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Tailored chemo doses may help seniors fight pancreatic cancer while staying independent

NCT ID NCT02143219

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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