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

NCT07844057 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 0000140473
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Small-bowel Adenocarcinoma; Metastatic Disease; Chemotherapy Effect

Outcome Measures

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.

  84 months

Secondary Outcomes (4)

• Median Overall survival (OS)

  84 months

• Objective response rate (ORR)

  84 months

• Patient Safety

  84 months

• Quality of life (QoL)

  84 months

Study Arms (2)

Treatment arm A: mFOLFIRINOX every two weeks

OTHER

* oxaliplatin 85 mg/m² 2 hours intravenously * irinotecan 150 mg/m² 60-90 minutes intravenously * leucovorin 400 mg/m² 2 hours intravenously * 5-fluorouracil 2400 mg/m² 46 hours continuous intravenous infusion

Drug: mFOLFIRINOX versus FOLFOX chemotherapy

Treatment arm B: FOLFOX every two weeks

OTHER

* oxaliplatin 85 mg/m² 2 hours intravenously * leucovorin 400 mg/m² 2 hours intravenously * 5-fluorouracil 400 mg/m² intravenous bolus injection * 5-fluorouracil 2400 mg/m² 46 hours continuous intravenous infusion

Drug: mFOLFIRINOX versus FOLFOX chemotherapy

Interventions

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 arm A: mFOLFIRINOX every two weeks; Treatment arm B: FOLFOX every two weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the trial only if all of the following criteria apply at time of enrollment:
• 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)
• Predicted locally advanced irresectable by the local study team or presenting with distant metastases.
• Patient did not receive antitumor treatment for locally advanced irresetable or metastatic disease.
• Measurable lesion according to RECIST 1.1.
• ECOG performance status 0-2. In case of patient's age \>70 years, ECOG has to be 0 or 1 at randomization
• Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results:
• Absolute neutrophil count 1.5 x 109/L (1500/µL)
• Hemoglobin ≥ 80 g/L (8 g/dL) with or without blood transfusion
• Platelet count ≥ 100 x109/L (100000/µL) without transfusion
• Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT) ≤ 2.5 × ULN; if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN

You may not qualify if:

• Patients are excluded from this trial if any of the following criteria apply at time of enrollment:
• 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.
• Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.
• Unstable angina pectoris.
• Unstable cardiac arrhythmia \>grade 2 NCI CTCAE despite anti-arrhythmic therapy.
• Ongoing toxicities \>grade 2 NCI CTCAE, in particular peripheral neuropathy.
• Active uncontrolled infection by investigator's perspective.
• Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture.
• Known hypersensitivity to 5-FU, leucovorin, capecitabine, irinotecan or oxaliplatin or to any of the other excipients listed in section 6.1 of the corresponding SmPC.
• Recent or concomitant treatment with brivudine.
• Peripheral sensitive neuropathy with functional impairment (\> grade 1 acc. to CTCAE version 6.0 (see appendix 2)).
• Simultaneous application of Johannis herbs preparations.

Sponsors & Collaborators

• Annika Kurreck: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: collaborator

Study Sites (16)

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

HELIOS Klinikum Bad Saarow

Bad Saarow, 15526, Germany

Location

Charité Berlin - CVK

Berlin, 13353, Germany

Location

Helios Klinikum Emil von Behring

Berlin, 14165, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Krankenhaus Nordwest GmbH- Institut für Klinisch-Onkologische Forschung

Frankfurt, 60488, Germany

Location

Marien Hospital Herne

Herne, 44625, Germany

Location

VK&K Studien GbR Landshut

Landshut, 84036, Germany

Location

Klinikum der LMU München - Medizinische Klinik und Poliklinik 3

München, 81377, Germany

Location

Rheinlandklinikum Lukaskrankenhaus Neuss

Neuss, 41464, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Elblandklinikum Riesa

Riesa, 01589, Germany

Location

Universitätsmedizin Rostock - Departement für Innere Medizin

Rostock, 18057, Germany

Location

Rostock Klinikum Südstadt

Rostock, 18059, Germany

Location

St. Josefs-Hospital Wiesbaden

Wiesbaden, 65189, Germany

Location

Cellitinnen Krankenhaus St. Petrus Wuppertal

Wuppertal, 42283, Germany

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annika Kurreck, PD Dr.

  Charité- Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aljoscha Joppe, Dr.

CONTACT

+49 (0) 69589978738; joppe.aljoscha@ikf-khnw.de

Inna Hoyer, Dr.

CONTACT

+49 30450553727; inna.hoyer@charite.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): April 1, 2034
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

DE (16)