Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
1 other identifier
interventional
518
1 country
2
Brief Summary
The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedOctober 20, 2010
October 1, 2010
October 14, 2010
October 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
Tumor evaluation using RECIST v1.1
every 8 weeks
Secondary Outcomes (2)
Safety
up to 4 weeks after last administration of chemotherapy
Overall survival
1 year
Study Arms (2)
paclitaxel
EXPERIMENTALPaclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle
irinotecan
EXPERIMENTALirinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle
Interventions
Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle
Eligibility Criteria
You may qualify if:
- Histologically confirmed gastric adenocarcinoma in tissue/cell
- Recurrent or metastatic gastric cancer that has progressed following first- line therapy
- Patients must be ≥18 years of age.
- ECOG performance status ≤ 2
- At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria
- Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin ≥ 9.0 g/dL White blood cells (WBC) ≥ 3000/µL Absolute neutrophil count (ANC) ≥ 1500/µL Platelet count ≥ 100 x 103/µL Total bilirubin ≤ 1.5 x upper normal limit (UNL) Creatinine clearance ≥ 60 ml/min or Serum creatinine ≤ 1.5 x UNL AST (SGOT)/ALT (SGPT) ≤ 2.5 x UNL unless liver metastases are present in which case it must be ≤ 5x UNL
- Life expectancy ≥ 12 weeks.
- Written informed consent
- Provision of informed consent for genetic research (In case of optional genetic research)
You may not qualify if:
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
- Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.
- Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years.
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
- Ongoing toxicities (\>CTCAE grade 2) caused by previous cancer therapy.
- Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding
- Medically uncontrolled, clinically significant heart disease or infection
- Patients with symptomatic uncontrolled brain metastases.
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.
- Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korean Cancer Study Grouplead
- Boryung Pharmaceutical Co., Ltdcollaborator
Study Sites (2)
Yonsei University Gangnam Severance Hospital
Seoul, 135-720, South Korea
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Lee KW, Maeng CH, Kim TY, Zang DY, Kim YH, Hwang IG, Oh SC, Chung JS, Song HS, Kim JW, Jeong SJ, Cho JY. A Phase III Study to Compare the Efficacy and Safety of Paclitaxel Versus Irinotecan in Patients with Metastatic or Recurrent Gastric Cancer Who Failed in First-line Therapy (KCSG ST10-01). Oncologist. 2019 Jan;24(1):18-e24. doi: 10.1634/theoncologist.2018-0142. Epub 2018 Aug 20.
PMID: 30126861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tae-You Kim, M.D., Ph.D.
Korean Cancer Stusy Group stomach Cancer Committee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 14, 2010
First Posted
October 20, 2010
Last Updated
October 20, 2010
Record last verified: 2010-10