This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
daily carbon ion radiotherapy
Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians.
Shanghai Proton and Heavy Ion Center (SPHIC)
Shanghai, Shanghai Municipality, China
Overall survival duration
The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.
Time frame: The length of time from randomization until death from any cause for up to 24 months
Progression-free survival duration
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time frame: he length of time from study registration until disease progression at any site or death from any cause, up to 24 months
Local disease progression scored using RECIST 1.1 criteria
A set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment
Time frame: Up to 24 months
Adverse events as defined by CTCAE v5.0
A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
Time frame: Up to 24 months
Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire
Questionnaire developed to measure the quality of life of cancer patients. Composite scores range from 0 to 100, with higher scores being more favorable.
Time frame: up to 24 months
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