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van CCT (UK)

van CCT (UK)

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

- candidate number21872
- NTR NumberNTR5143
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2015
- Secondary IDs 
- Public TitleShort-term palliative radiation for painful irresectable pancreatic cancer (PainPanc): a prospective phase 2 study
- Scientific TitleShort-term palliative radiation for painful irresectable pancreatic cancer (PainPanc): a prospective phase 2 study
- hypothesisPainreduction for 67% of patients with a locally advanced or local recurrent pancreatic carcinoma through a short radiotherapy scheme (single arm phase 2 study)
- Healt Condition(s) or Problem(s) studiedPancreas tumor, Pain
- Inclusion criteria1. Pain with a NRS 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 2
5. Diagnostic CT-scan not older than 3 months before study entry
6. Age 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
- Exclusion criteria1. Resectable or borderline resectable tumors without distant metastases
2. Endocrine pancreatic cancer or suspicion of metastasis in the pancreas
3. Pregnant woman
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-dec-2017
- Target number of participants30
- Interventionsradiotherapy 3 X 8 Gy, once per week.
- Primary outcomeTo 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 To determine the effect on pain free interval
To determine the reducing effect on (opiod) pain medication
To evaluate the effect on acute toxicity
To evaluate the correlation of radiation volume with acute toxicity
To evaluate the effect on quality of life
To evaluate the overall survival
- Timepointsbaseline, after each fraction, and at 4, 5, 7, 11, en 19 weeks after start of radiation and once per 3 months thereafter
- Trial web sitenone
- statusplanned
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsvan 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
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
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
- Brief summaryPancreatic 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.
- Main changes (audit trail)
- RECORD27-mrt-2015 - 21-mei-2015

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