Clinical trial · Interventional
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
A Pre-Surgical, Randomized Clinical Trial of Genistein in Resectable Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study has been closed due to no accrual.
Summary
Brief summary (as posted)
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving genistein before surgery may be an effective treatment for pancreatic cancer. PURPOSE: This randomized phase II trial is studying genistein to see how well it works in treating patients with pancreatic cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| genistein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive neoadjuvant oral genistein once daily for 2 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Dietary Supplement: genistein
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Patients receive no specific neoadjuvant therapy.
Primary outcomes (1)
- measure
- Changes in microvessel density of tumor specimen after 2 weeks of treatment with genistein
- timeFrame
- 2 weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults over the age of 18 capable of giving informed consent * resectable pancreatic mass, known or presumed to be primary pancreatic adenocarcinoma. Patients whose initial biopsy do not show adenocarcinoma will not receive the study drug. * ECOG preformance status 0-2. * Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment. Exclusion criteria: * comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol * hypersensitivity to genistein or to any of the excipients of genistein * prior chemotherapy or radiotherapy for pancreatic adenocarcinoma * concomitant use of warfarin, tamoxifen, or raloxifene. * pregnancy or inadequate contraception. * lactating females
References
Publications (0)
Data not yet available