Clinical trial · Interventional
Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas 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)
The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population. Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- All participants enrolled.
- interventionNames
- Radiation: Radiation Therapy
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
- timeFrame
- September 2012
Secondary outcomes (1)
- measure
- To determine tumor response rate, survival rate, local control rate and rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient Selection Criteria * Pathologically confirmed adenocarcinoma of the pancreas. * No distant metastases (no metastases beyond regional lymph nodes). * Deemed surgically unresectable by a surgical oncologist due to hepatic artery, celiac axis, superior mesenteric artery, superior mesenteric vein, portal vein, aorta, inferior vena cava, and/or rib/vertebral body involvement as defined by CT/MRI scan and/or endoscopic ultrasound (EUS). * No malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder. * No previous chemotherapy for pancreatic cancer. * No prior irradiation to the planned field. * Zubrod performance status 0-1. * Granulocytes \> 1,800, platelets \> 100,000/ul, bilirubin \< 2.0 mg/dL, ALT \< 3x upper limits of normal, creatinine \< 3.0 mg/dL. * No significant infection or other coexistent medical condition. * No pregnant or lactating women. * Age \> 18 years old. * Signed study-specific consent form prior to registration.
References
Publications (0)
Data not yet available