Development precision prognostic model through genotype-based optimization of tumor marker cut-offs under induction systemic therapy for pancreatic cancer 01/02

JRCT ID: jRCT1040230005

Registered date:11/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic Cancer
• Date of first enrollment: 14/01/2022
• Target sample size: 500
• Study type: Observational

Outcome(s)

• Primary Outcome: OOS
• Secondary Outcome: RFS

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

(1) Patients diagnosed with pancreatic cancer by various diagnostic imaging methods between January 1, 2010 and December 31, 2025 and who will receive induction chemotherapy (radiation therapy) (histological evidence is not required).
(2) Life expectancy is judged to be at least 6 months by the investigator(s).
(iii) Age at enrollment is between 20 and 79 years old.
Performance Status (ECOG) is 0 or 1.
(5) Patients must be undergoing initial treatment for pancreatic cancer (patients may be undergoing a series of treatments at the time of enrollment).
(6) No prior chemotherapy treatment within 3 years
(7) No concurrent cancer of other organs
(8) Able to take oral intake
(ix) If the patient has obstructive jaundice, appropriate drainage has been performed.
(10) Main organs are fully functional (within 14 days prior to enrollment).
White blood cell count: greater than 3,000/mm3 and less than 12,000/mm3
Neutrophil count: 1,000/mm3 or higher
Hemoglobin level: 8.0 g/dl or more
Platelet count: 75,000/mm3 or higher
Total bilirubin: 3.0 mg/dL or less*.
Patients undergoing antiasthmatic surgery for obstructive jaundice should be treated under 3.5 mg/dL.
AST and ALT levels: 150 U/L or less
Creatinine: 2.0 mg/dl or less
Creatinine clearance: 20 mL/min or more
(Estimation by the Cockcroft-Gault formula* is acceptable, but if actual measurements are available, the actual measurements will be used as the eligibility criteria.)
* Cockcroft-Gault formula
Male CCr = weight x (140 - age)/(72 x creatinine)
Female CCr = weight x (140 - age)/(72 x creatinine) x 0.85
(11) Consent for participation in this study has been obtained from the individual (However, if it is difficult to obtain informed consent because the individual is no longer attending the hospital or has died, please contact the Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, and the Department of Medicine, Faculty of Academic Research, University of Toyama, Department of Gastroenterology, University of Toyama. and Oncology and General Surgery, Nagoya Medical Center, and the Nagoya Medical Center Clinical Research Center will guarantee the opportunity to refuse by disclosing information on their websites.)

Exclude criteria

1 Patient's life expectancy is judged to be less than 6 months by the investigator(s)
2 History of serious drug hypersensitivity or drug allergy
3 Patients with obvious infection or inflammation (e.g., fever over 38.0)
4 Serious (requiring hospitalization) cardiac disease or history of cardiac disease
5 Have a serious (requiring hospitalization) underlying disease (intestinal paralysis, intestinal obstruction, diabetes mellitus that is difficult to control, renal failure, cirrhosis of the liver, etc.)
6 Have active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free period of less than 5 years. However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered cured by local treatment are not included in active overlapping cancers).
7 Ascites or pleural effusion that is difficult to control
8 Fresh gastrointestinal bleeding requiring repeated blood transfusions
9 Diarrhea (more than 4 times a day or watery stools)
10 Peripheral sensory neuropathy or peripheral motor neuropathy with CTCAE Grade 3 or higher
11 Pulmonary fibrosis or interstitial pneumonia that is evident on chest radiographs or is clinically symptomatic
12 Psychosis or psychiatric symptoms that would preclude participation in the study
13 Pregnant or lactating women and women of childbearing potential (intention)
14 Patients who did not give consent to participate in this study
15 Other patients who are judged by the investigator(s) to be unsuitable for the study.

Related Information

• Primary Sponsor: Kodera Yasuhiro
• Source(s) of Monetary Support: Kakenhi