Phase I study of mFFX-CRT for advanced pancreatic cancer

JRCT ID: jRCTs051220029

Registered date:25/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Invasive ductal carcinoma of the pancreas
• Date of first enrollment: 25/05/2022
• Target sample size: 24
• Study type: Interventional

Intervention(s)

modified FOLFIRINOX with concurrent radiation therapy:
The standard biweekly regimen of modified FOLFIRINOX is initiated with concurrent radiation therapy (1.8 gy, 29 fractions with total radiation dose of 50.4Gy). The dose of CPT-11 is increased according to the preplanned criteria as phase I setting.

Outcome(s)

• Primary Outcome: Dose limiting toxicity

Secondary Outcome

1) 1) Overall survival.
2) Alteration of tumor markers (CA19-9, DUPAN-II, or CEA) during chemoradiation therapy.
3) radiographic response (RECIST criteria).
4) Resection rate.
5) Pathological margin.
6) Recurrence-free survival.
7) Distant disease-free survival.
8) Local failure-free survival.
9) Treatment-related mortality or non-hematologic al toxicity with grade 4 or more.
10) Relative dose intensity of each chemotherapeutic agent.
11) Incidence of adverse events.
12) Postoperative complications (resected cases).
13) Details of the post-treatment after CRT.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients with histologically or cytologically confirmed invasive ductal carcinoma of the pancreas (IDC).
2) No distant diseases by radiographical evaluations.
3) Radiographically (MD-CT) confirmed invasive ductal carcinoma of the pancreas with BR-A and UR-LA disease according to the international consensus 2016 by the international association of pancreatology.
4) Age at consent: 18 to 75 years old.
5) Performance status according to ECOG criteria: 0 or 1.
6) No prior treatments with radiotherapy or surgery for the IDC.
7) Expected survival more than 3 months at consent.
8) No peripheral sensory or motor neuropathy of grade 2 or more.
9) Patients without the UGT1A1 status of 6/6, 28/28, 6/28.
10) Patients with major organs function maintained:
White blood cell counts: 3,000 and more, and 10,000(/mm3) or lower.
Neutrophil count: 1,500 or more (/mm3)
Hb: 10.0 or higher (g/dl)
Platelet count: 100,000 or more (/mm3)
Alb: 3.0 or higher (g/dl)
T-bil: 2.0(mg/dl) or lower
AST, ALT: 100(U/L) or lower
sCr: 1.2(mg/dl) or lower; Ccr: 50(ml/min) or higher
11) Patients with written informed consent to participate in this study.

Exclude criteria

1) Patients who are the potential candidates for other treatments, including the standard FOLFIRINOX and gemcitabine with nab-paclitaxel.
2) Patients with severe comorbidities.
3) Patients with unstable angina pectoris, or the histology of cardiac infarction and cerebral infarction within 6 months prior.
4) Patients with active concomitant malignancies in other organs with several exemptions (e.g., gastric cancer, stage 0-I).
5) Patients with active systemic infectious disease without several exemptions (e.g., virial hepatitis
with stable condition).
6) Patients with severe mental disorders.
7) Patients with systemic steroid therapy or other immunosuppression therapy.
8) Patients with radiographically evident ascites, excluding modest amount of ascites without clinical significance.
9) IDC with severe gastrointestinal invasion determined by radiographic or endoscopic examinations.
10) Patients with uncontrolled watery diarrhea.
11) Patients receiving atazanavir sulfate.
12) Patients with severe sensory or motor disfunctions.
13) Pregnant or potentially pregnant patients.
14) Patients receiving tegafur, gimeracil, oteracil potassium or received tegafur, gimeracil, oteracil po
tassium within 7 days prior.
15) Patients with severe drug anaphylaxis.
16) Patients with pulmonary fibrosis or interstitial lung disease.
17) Patients with contrast media allergy.
18) Other patients who are judged to be inappropriate for the entry of this study by the prin
cipal investigator or sub-investigator.

Related Information

• Primary Sponsor: Eguchi Hidetoshi
• Secondary Sponsor: Takahashi Hidenori