Selective Chemoradiation in Advanced LOcalised Pancreatic cancer

Phase 2

Completed

• Conditions: ocalised advanced non-metastatic pancreatic cancer (LANPC); Cancer; Pancreatic cancer

• Registration Number: ISRCTN96169987
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23474363 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26530749 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27497804 (added 14/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-29
• Study Completion: 2010-05-31
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Informed consent
2. Aged greater than or equal to 18 years, either sex
3. Histologically or cytologically confirmed inoperable (or medically unfit for surgery) adenocarcinoma of the pancreas
4. Chosen for non-surgical therapy by a specialised Multi-Disciplinary Team
5. World Health Organization (WHO) performance status 0 - 2
6. Neutrophils greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x 10^9/L and haemoglobin greater than or equal to 10 g/dL
7. Adequate liver function tests:
7.1. Serum bilirubin less than 35 µmol/l. In patients who have had a recent biliary drain and whose bilirubin is descending, a value of less than or equal to 50 µmol/L is acceptable.
7.2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN)
7.3. Alkaline phosphatase less than or equal to 5 x ULN
8. Adequate renal function (glomerular filtration rate [GFR] greater than 50 ml/min Cockcroft and Gault)
9. Women and men of child-bearing potential should agree to use an adequate contraception method, which must be continued for three months after completion of chemotherapy

Exclusion Criteria

1. Women who are pregnant or breast feeding
2. Any evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease
3. Any patient with myocardial infarction or stroke within the last six months
4. No previous malignancies in the preceding five years except for in situ cancer of the uterine cervix and adequately treated basal cell skin carcinoma and early stage malignancy
5. Renal abnormalities such as polycystic kidneys or hydronephrosis or ipsilateral single kidney
6. Previous radiotherapy to upper abdomen
7. Recurrent cancer following definitive pancreatic surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified