Clinical trial · Interventional
A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas
A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas
NCT05566743CI-TRIAL-00061206unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.
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 |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| follow up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the maintenance arm
- description
- in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine
- interventionNames
- Drug: Capecitabine
- type
- OTHER
- label
- the control arm
- description
- in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up
- interventionNames
- Other: follow up
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive adenocarcinoma of pancreas. * Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th Edition) 2017. * Measurable metastases according to RECIST 1.1. * Patients underwent surgical resection and postoperative evaluation revealed distant metastasis. * Patients with age ranging from 18 to 69. * WHO performance status 0-1. * An adequate bone marrow reserve and adequate liver and renal function as follow: Neutrophils ≥ 1500 cell/dl, Platelets ≥ 100,000 cell/dl, Hemoglobin ≥ 9.0 g/dl, Total bilirubin \< 1.5 × upper normal level (UNL), SGOT and SGPT \< 3 × UNL, Creatinine \< 1.5 × UNL or estimated GFR \> 30 ml/min. * Adjuvant and neoadjuvant chemotherapies will be permitted if administered more than 6 months before inclusion. * Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemotherapy. * All patients must have signed and dated informed consent form. Exclusion Criteria: * Endocrine or acinar pancreatic carcinoma. * Patients who progressed during FOLFRINOX regimen. * Pregnancy or breast feeding. * Patients with complicated systemic diseases such as diabetes, HTN or decompensated liver disease. * Patients with any serious uncontrolled medical conditions that might compromise study participation: Central nervous system disorders, gastrointestinal tract disorders that interfere with oral medication. * Patients with history of previous other carcinoma except basal cell carcinoma of the skin, insitu cervical carcinoma or non-metastatic prostate cancer. * More than grade 1 peripheral neuropathy. * Brain metastasis.
References
Publications (0)
Data not yet available
No reference posted for this study.