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First-line Treatment in Locally Advanced or Metastastic Small Bowel Adenocarcinoma

ConditionsSmall-bowel AdenocarcinomaMetastatic DiseaseChemotherapy Effect
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnnika Kurreck

About this trial

Phase II randomized trial evaluating modified FOLFIRINOX and FOLFOX in the treatment of locally advanced or metastatic small bowel adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient's signed informed consent.

Patient's age ≥18 years at the time of signing the informed consent.

Histologically confirmed small bowel adenocarcinoma.

Microsatellite stable tumor or proficient mismatch repair status of the SBA (immunohistochemistry and polymerase chain reaction are both allowed for characterization)

Disqualifiers

Adenocarcinoma of the ampulla of Vateri

Ileus or directly imminent ileus as assessed by the local study team. Patients with treated and resolved ileus are allowed into the trial.

Previous chemotherapy for metastatic or irresectable disease.

New York Heart Association Class III or greater heart failure by clinical judgement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mFOLFIRINOX versus FOLFOX chemotherapy

    Drug

    Systemic treatment in both arms will be continued until disease progression, occurence of unacceptable toxicity, at the patient's request, at discretion of the investigator, whatever occurs first.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Treatment arm A: mFOLFIRINOX every two weeksOther 1 intervention
Group B: Treatment arm B: FOLFOX every two weeksOther 1 intervention

Trial outcomes

Primary outcomes

1

Median Progression-free survival (PFS)

Progression-free survival (PFS)-, defined as time from the date of randomization to the date of first radiological disease progression according to RECIST version 1.1 or the date of death from any cause.

Time frame
84 months

Secondary outcomes

1

Median Overall survival (OS)

Time frame
84 months
2

Objective response rate (ORR)

Time frame
84 months
3

Patient Safety

Type, incidence, severity, and causal relationship to study treatment of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 6.0)

Time frame
84 months
4

Quality of life (QoL)

Quality of life (QoL) as assessed with the QoL questionnaire EQ-5D-5L

Time frame
84 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Annika Kurreck

Lead sponsor

Charite University, Berlin, Germany

Sponsor institution

Deutsche Krebshilfe e.V., Bonn (Germany)

Collaborator

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: