The main goal of the current randomized study is to investigate if SABR may relieve tumor-related symptoms, improve the quality of life and potentially prolong survival in this frail patient group compared to best supportive care, which is the…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Health condition
pancreascarcinoom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to compare survival at six months in both study arms,
measured from the time of randomization.
Secondary outcome
- Quality of life (QoL) assessment using the European Organization for Research
and Treatment of Cancer (EORTC)
quality-of-life score questionnaires (QLQ-C30, version 3.0 and EORTC-PAN26)
assessed at baseline, 3-6-12 months
• Ca19.9: assessed at baseline, 3 and 6 months
• Toxicity will be scored using CTCAE criteria version 5.0: assessed at
baseline, day of last fraction, at 3 and 6 weeks (telephone consultation by
Radiation Oncologist), 3-6-12 months
• NRS pain score: assessed at baseline, 3-6-12 months
• WHO performance score: assessed at baseline, 3-6-12 months
Imaging after 3-6- and 12 months after treatment
Background summary
Pancreatic ductal adenocarcinoma (PC) is one of the most lethal cancers, its
incidence increases with age. Many patients with localized (non-metastatic) PC
have significant comorbidities, advanced age or a poor performance status which
preclude chemotherapy and surgery. Because these patients are currently left
untreated, it is desirable to find tolerable treatment options for these
patients. A short course of high-dose precise radiation therapy i.e.
stereotactic ablative body radiotherapy (SABR) may be feasible in these
patients. Review of existing SABR literature for PC shows high local control
rates, with relatively low toxicity and it was demonstrated to be feasible and
well tolerated even in frail and elderly patients. It is, however, unknown
whether SABR in the abovementioned poor prognosis subgroup of patients improves
outcomes.
Study objective
The main goal of the current randomized study is to investigate if SABR may
relieve tumor-related symptoms, improve the quality of life and potentially
prolong survival in this frail patient group compared to best supportive care,
which is the current treatment of choice in these patients.
Study design
This study is a multicentre randomized controlled trial according to the
*cohort multiple randomized controlled trial (cmRCT)-design.
PACAP-participants have provided informed consent for being randomized in
future unspecified cmRCTs. According to the cmRCT design, randomly selected
patients will be informed about their random selection to receive the
intervention within this trial, SABR. Furthermore, they will be informed that
they are free to decide whether they want to adhere or deny this intervention
for which they were randomly selected. In addition to spoken information, also
written information will be provided to the patient. Patients have at least
three days to read the information and consider their consent after which the
(local) investigator or an authorized delegate will encounter the patient again
for informed consent.
SABR will eventually be administered to patients within four weeks after
written consent.
Intervention
Five fractions of 8 Gy
Study burden and risks
Acute SABR-related toxicity may consist of fatigue, nausea, diarrhoea and
temporary (increase of) local pain. Premedication can be prescribed to restrict
such events. Subacute and late effects following high dose SABR can consist of
gastrointestinal toxicity in the form of duodenal haemorrhage, strictures,
ulceration or perforation, although literature findings suggest the incidence
of these to be less than 5%.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
• Pathology proven localised (non-metastasized) PC. Or when retrieving PA is
difficult a multidisciplinary tumor board consensus on the diagnosis.
• Patients unfit for both surgery and systemic chemotherapy (i.e. KPS 50-70;
WHO 2 or favourable WHO3) or patients who refuse surgery or chemotherapy.
In case of prior treatment with chemotherapy: A maximum of two cycles of
chemotherapy is allowed for inclusion. The interval between the last cycle of
chemotherapy and the first fraction of radiation therapy should be at least six
weeks. Additionally, in the case patient suffered from side effects of the
chemotherapy these have to score equal or below 1 (CTCAE v.5.0) in before the
first fraction of radiation therapy is delivered.
• Written informed consent
Exclusion criteria
• Age <18 years
• Administration of more than two cycles of chemotherapy
• Distant metastasis
• Imminent bowel obstruction
• Active bleeding
• Uncontrolled infection
• Contra-indications for MRI (only for VUmc and UMCU)
- pacemakers or implanted defibrillators, deep brain stimulators, cochlear
implants. Patients who have a metallic foreign body in their eye, or who have
an aneurysm clip in their brain, cannot have an MRI scan since the magnetic
field may dislodge the metal
- Patients with severe claustrophobia not able to tolerate an MRI scan
- Patients with a non-MR-compatible (hip/knee/jaw) prosthesis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72181.029.20 |