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Short-term palliative radiation for painful irresectable pancreatic cancer (PainPanc): a prospective phase 2 study

Conditions
Painful Locally advanced or locally recurrent pancreatic cancer
Registration Number
NL-OMON20425
Lead Sponsor
Academic Medical CenterMeibergdreef 91105 AZ Amsterdam, the Netherlands
Brief Summary

van Geenen RC, Keyzer-Dekker CM, van Tienhoven G, Obertop H, Gouma DJ. Pain management of patients with unresectable peripancreatic carcinoma. World J Surg. 2002;26:715-20<br> Ceha HM, van Tienhoven G, Gouma DJ, Veenhof CH, Schneider CJ, Rauws EA, et al. Feasibility and efficacy of high dose conformal radiation for patients with locally advanced pancreatic carcinoma. Cancer. 2000;89:2222-9<br> Morganti AG, Trodella L, Valentini V, Barbi S, Macchia G, Mantini G, et al. Pain relief with short-term irradiation in locally advanced carcinoma of the pancreas. J Palliat Care. 2003;19:258-62

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

1. Pain with a NRS ¡Ý 2 as a result of pancreatic cancer, not sufficiently responding to oral, transdermal pain medication or celiac plexus blockade.

2.Primarily irresectable or locally recurrent pancreatic cancer with or without metastases

Exclusion Criteria

1.Resectable or borderline resectable tumors without distant metastases

2.Endocrine pancreatic cancer or suspicion of metastasis in the pancreas

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate whether pain relief is successful 4 weeks after the last radiation (7 weeks after start of treatment) . A short course of radiation (3 x 8 Gy) will be given in patients with painful irresectable pancreatic cancer, primary or recurrent.
Secondary Outcome Measures
NameTimeMethod
•To determine the effect on pain free interval <br /><br>•To determine the reducing effect on (opiod) pain medication<br /><br>•To evaluate the effect on acute toxicity<br /><br>•To evaluate the correlation of radiation volume with acute toxicity<br /><br>•To evaluate the effect on quality of life <br /><br>•To evaluate the overall survival <br />
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