Clinical trial · Interventional
Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)
Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma
- 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 study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.
Conditions
Conditions (2)
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 Stage II | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer Stage III | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, capecitabine, docetaxel followed by radiotherapy | Drug | — | UNRESOLVED |
| Neoadjuvant gemcitabine, capecitabine, and docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I
- description
- Patients with only venous involvement Treated with 6 cycles og GTX and then surgery
- interventionNames
- Drug: Neoadjuvant gemcitabine, capecitabine, and docetaxel
- type
- EXPERIMENTAL
- label
- Group II
- description
- Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery
- interventionNames
- Drug: Gemcitabine, capecitabine, docetaxel followed by radiotherapy
Primary outcomes (1)
- measure
- To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.) * Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan. * No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan. * Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both) * No prior chemotherapy or radiation therapy. * Ineligible for other high priority national or institutional studies. * Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females. * Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy. * Complete Blood Count and Complete Metabolic Profile: Absolute Neutrophil Count \> 1,500 μl White Blood Count \> 3,000/μl Platelet count \> 100,000/μl BUN \< 1.5 x normal Creatinine \< 1.5 normal Hemoglobin \> 8.0 g/dl Serum Albumin \> 3 mg/dl Total Bilirubin \< 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase \< 2.5 x ULN * Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
References
Publications (1)
- DERIVEDSherman WH, Chu K, Chabot J, Allendorf J, Schrope BA, Hecht E, Jin B, Leung D, Remotti H, Addeo G, Postolov I, Tsai W, Fine RL. Neoadjuvant gemcitabine, docetaxel, and capecitabine followed by gemcitabine and capecitabine/radiation therapy and surgery in locally advanced, unresectable pancreatic adenocarcinoma. Cancer. 2015 Mar 1;121(5):673-80. doi: 10.1002/cncr.29112. Epub 2014 Dec 9. PMID 25492104