Ignite Creation Date:
2024-05-06 @ 12:38 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03817268
Status:
RECRUITING
Last Update Posted:
2020-04-20
First Post:
2019-01-18
Brief Title:
Capecitabine or Observation for Patients With pT1NM0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection
Sponsor:
The First Affiliated Hospital of Anhui Medical University
Organization:
The First Affiliated Hospital of Anhui Medical University
Study Overview
Official Title:
Capecitabine or Observation for Patients With pT1NM0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection CAPOGA A Large Multicenter Phase III Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPOGA
Brief Summary:
Gastric cancer GC is one of the most common and lethal malignancies in Asia For early stage T1 GC it has been found by analyzing surgical specimens that 5 of cancers have lymph node metastasis For patients with stage T2-3N0M0 GCs there is a considerable probability of micro-metastasis While the US National Comprehensive Cancer Network NCCN the Japanese Gastric Cancer Association JGCA and the European Society for Medical Oncology ESMO guidelines recommend adjuvant therapy for most patients with resected T1N0 GCs the recommendations vary regarding postsurgical treatment for patients with stage T1NM0 or T2-3N0M0 disease The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population while the ESMO support the adjuvant treatment The NCCN has not offered a definitive recommendation on this issue Through careful literature search there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1NM0 or T2-3N0M0 GC The first-line chemotherapy regimen for GC is fluorouracil plus platinum Among fluorouracil platinum is especially favored due to its less frequent and less severe adverse effects This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery The First Affiliated Hospital of Anhui Medical University and carried out in multiple Chinese centers aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1NM0 or T2-3N0M0 GC undergoing R0 Resection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None