Phase 2
Completed N=29
Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Source: ClinicalTrials.gov NCT00089024 ↗Enrolled (actual)
29
Serious AEs
86.2%
Results posted
Oct 2019
Primary outcomePrimary: Surgical Exploration — 4; 6; 9 Participants
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients who may undergo surgery for locally advanced pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Exploration |
4; 6; 9 | — |
| PRIMARY Number of Participants Experiencing Grade 3-4 Toxicity While Receiving the Study Treatment |
4; 5; 11; 0; 12; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of adenocarcinoma of the pancreas
o Locally advanced disease
- Potentially resectable disease
- 19 years of age and over
- Karnofsky 60-100%
- Absolute granulocyte count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 2.0 mg/dL (in the absence of biliary obstruction)
- If biliary obstruction is present, patients must undergo biliary decompression
- Bilirubin ≤ 3.0 mg/dL after biliary drainage has been established
- Creatinine ≤ 1.6 mg/dL
Exclusion Criteria
- No early stage resectable disease
- No concurrent non-steroidal anti-inflammatory medication
- No evidence of distant metastases to the liver or peritoneal area according to imaging studies and laparoscopic staging
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No serious uncontrolled cardiac arrhythmia
- Not pregnant or nursing
- No uncontrolled illness
- No active or ongoing infection requiring IV antibiotics
- No marked intolerance to 5-fluoropyrimidines (i.e., fluorouracil, floxuridine, capecitabine, or fluorocytosine)
- No allergy to sulfonamides, aspirin, or non-steroidal anti-inflammatory drugs
- No allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with study chemotherapy
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
- No prior chemotherapy for pancreatic cancer
- No prior abdominal radiotherapy
Data sourced from ClinicalTrials.gov (NCT00089024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.