Painreduction for 67% of patients with a locally advanced or local recurrent pancreatic carcinoma through a short radiotherapy scheme (single arm phase 2 study)
Painful Locally advanced or locally recurrent pancreatic cancer
1105 AZ Amsterdam, the Netherlands
Onderzoeksproduct en/of interventie
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.
Achtergrond van het onderzoek
Pancreatic cancer has an extremely poor prognosis. It is the fifth leading cause of cancer death in the Netherlands with an overall 2-year survival of less than 10%. This has hardly improved over the last two decades. Less than 15% of all patients present with resectable disease. The majority of patients have locally advanced and/or metastasized disease and are treated with palliative intent.
Pain is an important symptom in pancreatic cancer and leads to a strong reduction in quality of life. At time of diagnosis, 30-40% of the patients report pain as a dominant symptom which rises to 90% shortly before death. Inadequate pain control may lead to a situation where pain becomes disabling and requires hospitalization for pain management. Therefore successful pain management is often viewed as the key management for a better quality of life. Pain management options range from pharmacologic treatment to invasive treatment such as nerve blockades. Radiation has also shown to give pain reduction, even though not much research has been done. With this study we would like to research and document the pain relief of shortcourse radiation and the effect of quality of life.
Doel van het onderzoek
Painreduction for 67% of patients with a locally advanced or local recurrent pancreatic carcinoma through a short radiotherapy scheme
(single arm phase 2 study)
baseline, after each fraction, and at 4, 5, 7, 11, en 19 weeks after start of radiation and once per 3 months thereafter
Onderzoeksproduct en/of interventie
radiotherapy 3 X 8 Gy, once per week.
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
3. Preferably histological or cytological confirmed adenocarcinoma of the pancreas
4. WHO performance status ¡Ü 2
5. Diagnostic CT-scan not older than 3 months before study entry
6. Age ¡Ý 18 years
7. If the patient is or was treated with chemotherapy, time interval between the course of chemotherapy and start of radiation should at least be 14 days.
8. Written informed consent
9. The ability to answer and fill out the questionnaires
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Resectable or borderline resectable tumors without distant metastases
2. Endocrine pancreatic cancer or suspicion of metastasis in the pancreas
3. Pregnant woman
In dit register bekende (historische) registraties
Geen registraties gevonden
In overige registers
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