JPRN-jRCTs041230012RecruitingPhase 2
A Phase II Study to Investigate the Efficacy and Safety of Oral intake of Anamorelin in Patients After Total Gastrectomy
Bando Etsuro0 sites65 target enrollmentStarted: April 20, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 65
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to <= 85age old (—)
- Sex
- All
Inclusion Criteria
- •1) Total gastrectomy for gastric cancer has been performed for more than 1 year and no evident recurrence is observed.
- •2) Histologically diagnosed gastric cancer (special type is acceptable) at the time of surgery.
- •3) Total gastrectomy with D1+, D2, D2+ No. 10 lymph node dissection or D2+PAND, and there was no residual cancer macroscopically at the time of surgery (residual tumor at surgery was R0 or R1).
- •4) Any distance of esophageal involvement, with the exception of cases of right open chest with concomitant sub-total esophagectomy.
- •5) The surgical approach performed was one of the following.
- •1 Open total gastrectomy was performed regardless of the degree of preoperative
- •clinical staging.
- •2 Laparoscopic or robot-assisted total gastrectomy was performed regardless of the
- •degree of the preoperative clinical staging. The operator or teaching assistant for laparoscopic or robot-assisted surgery must be performed by the surgeon technically certified by the Japanese Society for Endoscopic Surgery.
- •6) Age at the time of informed consent is 85 years old or younger.
- •7) Acceptable after total remnant gastrectomy.
- •8) It does not matter whether preoperative chemotherapy or postoperative adjuvant chemotherapy were performed or not, but it is necessary that more than 4 weeks have passed since the end of postoperative chemotherapy at the time of registration.
- •9) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1.
- •10) It is judged that oral intake is possible and oral administration of anamorelin hydrochloride (Edolmizu Tablets) can be safely started.
- •11) The latest test value within 84 days before registration (same day of the week 1 week before the registration date is acceptable) meets all of the following.
- •1 White blood cell count>= 3,000/mm3
- •2 Hemoglobin>=8.0g/dL
- •3 Platelet count>= 100,000/mm3
- •4 AST<=100U/L, ALT<=100U/L
- •5 Total bilirubin<= 2.0mg/dL
- •6 Serum creatinine<= 2.0 mg/dL
- •12) A score of 17 or less out of 20 on the FAACT anorexia questionnaire.
- •13) Written consent has been obtained from the patient to participate in this study.
Exclusion Criteria
- •1) Diabetes mellitus,cardiopulmonary disease, osteoarthritis, neurological disease, etc., make safe evaluation and intervention difficult.
- •2) Diagnosed with myocardial infarction or unstable angina within 6 months of registration.
- •3) Complicated with psychosis or psychiatric symptoms, and it is judged difficult to participate in clinical trials.
- •4) Diagnosed with dementia.
- •5) Inability to digest or absorb food or oral medications (chronic nausea, vomiting, diarrhea, gastrointestinal obstruction, hypercalcemia, patients under parenteral nutrition management, gastrointestinal organics associated with radiotherapy) disability, etc.)
- •6) Patients receiving the following drugs and foods: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing preparations, cobicistat-containing preparations, carbamazepine, phenytoin, phenobarbital, rifabutin, rifampicin, St. John's wort, containing food, grapefruit.
- •7) Diagnosed with moderate or severe liver dysfunction (Child-Pugh classification B and C).
- •8) Meet any of the following cardiac function criteria
- •1 Angina pectoris or myocardial infarction within the past 3 months
- •2 Patients with second- or third-degree atrioventricular block
- •3 Sinus bradycardia with a heart rate of less than 40 beats/minute, sinoatrial block, sick
- •sinus syndrome, or persistent arrhythmia greater than Grade 2 (Patients with stable
- •chronic atrial fibrillation receiving anticoagulant therapy should allow)
- •4 Complete left bundle branch block, complete right bundle branch block with advanced
- •axial variation, severe premature ventricular contractions (multifocal, 2 or more shots, or
- •R on T phenomenon)
- •5 Patients with congestive heart failure or decreased cardiac function
- •9) In addition, the attending physician is judged to be inappropriate for registration in this clinical trial.
- •10) Has a history of hypersensitivity to ingredients of anamorelin hydrochloride (Edolmizu Tablets).
Investigators
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