Clinical trial · Interventional
A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease
- 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)
This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine/Nab-paclitaxel, Radiation and Surgery
- description
- Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles. Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles. Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction) Surgery: Tumor resection and arterial resection/reconstruction
- interventionNames
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
- Radiation: Radiation Therapy
- Procedure: Surgical Resection
Primary outcomes (1)
- measure
- Type and the severity of side effects
- timeFrame
- 5 years
Secondary outcomes (8)
- measure
- Number of surviving patients at 1 year after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Surgical: * Medically fit for major pancreatic surgery * No evidence of metastases * No prior resection * Arterial involvement limited to a single major vessel and is resectable * Tumour-free margins could be achieved * Acceptable length of vessel * Mass considered otherwise resectable by current standards General: * Less than 70 years old * Performance status \<=2 * Has pancreatic adenocarcinoma * Adequate bone marrow and organ function * Therapeutic heparin is allowed * Taking chronic erythropoietin are permitted * Not pregnant * Agree to use contraception * Able to provide written consent Exclusion Criteria: Surgical: * Aortic involvement * Involvement of 2 major arterial trunks * SMV/portal venous occlusion, cannot be reconstructed * Extensive venous involvement, no arterial involvement * Disease progression on neo-adjuvant treatme General: * Concurrent cancer diagnosis * Other malignancies unless all therapy completed, no disease for \>=3 years * Prior radiotherapy or chemo within 1 year, to pancreas * Bone marrow transplant/stem cell rescue * Major surgery \<4 wks prior * Distant metastases * Renal dysfunction * Pulmonary insufficiency * History of cardiac disease * Active systemic infection(s) or any other related illnesses * Known HIV, HBV, HCV * History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy * Conditions interfering with patient participation * Known or suspected allergy to study drugs * Pregnant or breast-feeding * Therapeutic coumadin * More than or equal to Grade 2 pre-exiting peripheral neuropathy
References
Publications (0)
Data not yet available