Stomach Neoplasm Clinical Trial
Official title:
A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy
Patients with recurrent or metastatic gastric cancer can benefit from palliative
chemotherapy. However, over half of patients with metastatic gastric cancer who received
chemotherapy failed to achieve response and even in these responders, the duration of
responses was as short as a few months. Patients with metastatic gastric cancer who fail to
respond or have relapse after first line chemotherapy have a grim prognosis and a standard
salvage treatment is not available.
We designed this phase II trial to determine the efficacy and safety of irinotecan
monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - histologically confirmed gastric cancer - inoperable, recurrent, or metastatic - performance status 0 to 2 - failed after one or more prior chemotherapy for advanced disease - informed consent Exclusion Criteria: - active infection - severe co-morbidities - previously treated with irinotecan or similar drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gachon University Gil Medical Center | Incheon |
Lead Sponsor | Collaborator |
---|---|
Gachon University Gil Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate | |||
Secondary | safety |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03313700 -
Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
|
N/A | |
Recruiting |
NCT05645198 -
The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy
|
Phase 4 | |
Completed |
NCT03549494 -
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
|
Phase 2 | |
Completed |
NCT00935779 -
Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer
|
N/A | |
Completed |
NCT00144378 -
Irinotecan Versus Only Best Supportive Care for Gastric Cancer
|
Phase 3 | |
Completed |
NCT00290966 -
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT03348150 -
Gastrectomy + Cytoreductive Surgery + HIPEC for Gastric Cancer With Peritoneal Dissemination.
|
Phase 3 | |
Not yet recruiting |
NCT06085677 -
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
|
||
Recruiting |
NCT02969122 -
Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor
|
N/A | |
Completed |
NCT01482299 -
RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression
|
Phase 2 | |
Active, not recruiting |
NCT03760822 -
Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients
|
Phase 2 | |
Completed |
NCT04889859 -
Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
|
N/A | |
Completed |
NCT03071237 -
The Origin of Infrapyloric Artery
|
||
Recruiting |
NCT05184803 -
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
|
Phase 2 | |
Completed |
NCT05714878 -
Multimodal Prehabilitation for Resectable Gastric Cancer
|
N/A | |
Completed |
NCT00142038 -
Docetaxel and Capecitabine in Advanced Gastric Cancer
|
Phase 2 | |
Not yet recruiting |
NCT04056260 -
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer
|
N/A | |
Recruiting |
NCT03065257 -
Endoscopic Resection Multicenter Registry
|
N/A | |
Recruiting |
NCT04744649 -
Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial
|
Phase 2 | |
Recruiting |
NCT05640609 -
Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
|
Phase 1/Phase 2 |