RINDBeRG trial

JRCT ID: jRCTs051180187

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 26/03/2019
• Target sample size: 400
• Study type: Interventional

Intervention(s)

Irinotecan alone group
IRI 150 mg/m2, day 1 q2w

Ramucirumab plus irinotecan group
RAM 8 mg/kg day1, q2w
IRI 150 mg/m2, day1, q2w

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: progression-free survival (PFS); time to treatment failure (TTF); response rate (RR); disease control rate (DCR); and adverse events (AEs)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy.
2) Documented objective radiographic or clinical disease progression directly after a ramucirumab-containing chemotherapy.
3) No previous history of IRI administration.
4) Neither tolerates nor responds to treatment with fluoropyrimidines, platinum, or taxanes.
*Does not respond is defined as: progression or recurrence of the tumor during chemotherapy or within 180 days after final chemotherapy.
**Does not tolerate is defined as: discontinuation of treatment due to safety reasons such as allergic reactions, neurotoxic or other toxic effects that delay recovery.
*** Patients without prior platinum, if the tumor recurs within 180 days after perioperative adjuvant chemotherapy such as S-1 monotherapy or S-1 / docetaxel, and then disease progression after a ramucirumab - containing chemotherapy, are eligible.
5)Has lesions that can be evaluated on CT or MRI images (measurable or non-measurable lesions according to RECIST ver. 1.1).
6)Age at enrollment =>20 years old.
7)ECOG performance status (PS) of 0 or 1 at study entry.
8)Oral intake is possible.
9)Adequate organ function, defined as no severe impairment of bone marrow, heart, lungs, liver or kidneys, and laboratory values at the start of treatment that meet the following criteria. (For enrollment, the most recent data within 14 days after the day of enrollment shall be used. The laboratory data of the day of enrollment shall be used as a reference. However, it is also possible to use the laboratory data that were obtained on the same weekday 2 weeks before.)
1.Absolute neutrophil count (ANC): =>1,500/mm3
2.Total bilirubin: =>8.5 g/dL
3.Platelet count: =>100,000/mm3
4.AST, ALT: =<100 IU/L (=<150 IU/L in patients with liver metastasis)
5.Total bilirubin: =<1.5 mg/dL
6.Serum creatinine: =<1.5 mg/dL, or creatinine clearance: =>40ml/min (estimated creatinine clearance rate using the Cockcroft-Gault formula or creatinine concentration measured after 24-hour urine collection)
7.Urinary protein: =<(1+) on dipstick or routine urinalysis or =>2 g/24 hours after 24-hour urine collection, or urinary protein/creatinine ratio <2
10)Life expectancy of at least 3 months.
11) Written informed consent obtained prior to any study-specific procedures.

Exclude criteria

1) History of another malignancy (simultaneous double cancers / multiple cancers and metachronous double cancers with a disease-free period of 5 years / multiple cancers; however, this does not include other malignancies / double cancers in carcinoma in situ that were judged to be curable by local treatment and intramucosal cancers).
2) Previous systemic chemotherapy with an angiogenesis inhibitor, except ramucirumab.
3) History of serious adverse events after treatment with RAM.
4) Uncontrolled arterial hypertension (e.g. =>150/90mmHg despite standard treatment).
5) Uncontrollable diarrhea that interferes with everyday activities even if receiving adequate treatment.
6) Undergoing anticoagulant therapy for the treatment of thromboembolism.
7) Local or systemic active infection that requires treatment (however, patients who are hepatitis B surface antigen (HBsAg) positive can also be enrolled if the disease can be controlled with a nucleic acid analogue and the patient was confirmed to be HBV-DNA negative).
8) Serious illness or medical condition(s) including, but not limited to the following: gastrointestinal bleeding, enteroparalysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, symptomatic heart disease (including ischemic heart disease, myocardial infarction, and heart failure), renal failure, liver cirrhosis, glaucoma, uncontrollable diabetes mellitus, etc.
9) History of severe allergy or hypersensitivity to any drugs.
10) Transfusion treatment within 2 weeks prior to enrollment.
11) Moderate or large ascites or pleural effusion.
12) Continuous systemic steroid treatment.
13) Evidence of a psychological disorder that is judged to make it difficult to ensure the continuous use of the study drug.
14) Symptomatic evidence of known central nervous system metastases.
15) Daily treatment with atazanavir sulfate, which is incompatible with IRI.
16) Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study.
17) Duplicate in other interventional clinical studies.
18) Any condition that suggests that the patient is, in the investigator's opinion, not an appropriate candidate for the study.

Related Information

• Primary Sponsor: SATOH Taroh
• Source(s) of Monetary Support: Eli Lilly Japan K.K.
• Secondary ID(s): UMIN000023065