Unresectable advanced pancreatic cancer
Conditions
Interventions
In addition to chemotherapy with GnP, lactitol 6 g is administered twice daily (morning and evening). The trial treatment period consists of an initial 3-month phase followed by a subsequent 3-month p
Sponsors
Abiru Seigo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with pancreatic cancer that is unresectable or has distant metastases on contrast-enhanced CT, with elevated levels of CA19-9, Dupan-2, or CEA. (2) Patients who have not previously received chemotherapy for pancreatic cancer. (3) Patients who are considering treatment with GnP (gemcitabine hydrochloride + nab-paclitaxel). (4) Patients with an ECOG PS of 0-2. (5) Patients who are 20 years of age or older at the time of informed consent and have the capacity to make decisions.
Exclusion criteria
Exclusion criteria: Patients for whom Gemzar and Abraxane are contraindicated (1) Patients with severe bone marrow suppression [bone marrow suppression may worsen and be life-threatening] (2) Patients with interstitial pneumonia or pulmonary fibrosis evident on a plain chest X-ray and accompanied by clinical symptoms [symptoms may worsen and be life-threatening] (3) Patients undergoing radiation therapy to the chest (4) Patients with severe infections [Infections may worsen and become life-threatening.] (5) Patients with a history of severe hypersensitivity to any component of this drug (6) Pregnant patients (7) Patients whom the treating physician considers unable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether lactitol enhances antitumor effects, the response rate will be compared three months after the start of the test treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Using GnP as the baseline, compare the response rates at 3 months between the lactitol-free group and the lactitol-combination group with an external control group of GnP cases. | — |
Contacts
Public ContactRyuta Takeda
NHO Saga Hospital
Outcome results
None listed