Examination of the safety and usefulness of preoperative chemotherapy and radiation therapy for locally advanced pancreatic cancer (Phase I / II)

JRCT ID: jRCT1031200325

Registered date:27/01/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally advanced pancreatic cancer
• Date of first enrollment: 27/01/2021
• Target sample size: 58
• Study type: Interventional

Intervention(s)

As a general rule, the first course is hospitalized and performed, but after the second course, outpatient treatment is possible at the discretion of the attending physician while observing the patient's condition.
<Gemcitabine hydrochloride + NabPTx therapy>:
Gemcitabine hydrochloride 1000mg / m2 and NabPTx 125mg / m2 are intravenously infused on the same day, and the treatment is given once a week for 3 consecutive weeks, and the 4th week is a course of withdrawal.
<IMRT>
Irradiation should be done within a maximum of 10 weeks.
The planned CT that determines the irradiation range will be taken after obtaining consent.
Irradiation should be started after the end of the first and second GnP administration (Day 9 and after) and before the end of the first course (Day 28).

Outcome(s)

Primary Outcome

Optimal radiation dose
Transition rate to radical surgical resection

Secondary Outcome

Incidence of adverse drug/radiation reactions
Progression-free survival in patients with inoperable conversion and BR pancreatic cancer inoperable
Recurrence free survival in patients undergoing Conversion surgery and BR pancreatic cancer surgery
Response rate
Disease control rate
1-year and 2-year survival rates
Tumor markers: Changes in serum CEA, CA19-9, DUPAN, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Patients who have been confirmed by histological or cytological examination to have pancreatic cancer.
2) Patients with locally advanced pancreatic cancer who do not have distant metastasis and the tumor has spread to the surrounding arteries and veins, making curative resection difficult.
3) Patients who have not received prior treatment for this disease prior to enrollment
4) Patients whose age at registration is 20 years or older and under 80 years old
5) Patients with Performance status (ECOG) of 0,1
6) Patients who are expected to survive for more than 3 months from the start of treatment
7) Patients who retain the functions of major organs (bone marrow, liver, kidneys, lungs, etc.)
8) Patients with sufficient urine output
9) Patients who can take orally
10) Patients with written consent

Exclude criteria

1) Patients with non-curative factors during radical resection
2) Patients with overt pulmonary fibrosis or interstitial pneumonia
3) Patients with active infections (HB, HCV, HIV infections, etc.)
4) Patients with heart failure, angina, arrhythmia and myocardial infarction within 6 months of onset that are difficult to control despite treatment
5) Patients with uncontrollable diabetes
6) Patients with watery diarrhea
7) Patients using flucytosine and phenytoin
8) Pregnant women, lactating and patients with or willingness to become pregnant
9) Patients with severe drug allergies
10) Patients with active double cancer (not applicable to cases 5 years after complete cure)
11) Patients with other serious complications
12) Patients with severe neuropsychiatric symptoms and renal disorders
13) Patients with hearing impairment
14) Chickenpox patients
15) Patients with prior treatment history for this disease
16) Other patients who the doctor in charge judged to be inappropriate for conducting this study safely

Related Information

• Primary Sponsor: Uwagawa Tadashi