Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-28 @ 2:34 PM
Study NCT ID:
NCT01286766
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2011-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2024-12
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:
None
Brief Summary:
Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.
Detailed Description:
Treatment scheme
* Screening period: D-21 to D1 (treatment day)
* Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
* Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
* Tumor response is assessed every 2 cycles (6 weeks)
* Treatment is repeated until,.
* 4 cycles
* progressive disease
* unacceptable toxicity
* patient's withdrawal
* Gastric surgery should be performed within 4\~6 weeks of the last dose of chemotherapy
* Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
* Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
* Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
* Follow up for survival is repeated every 3 months for 2 years
Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months
* Screening period: D-21 to D1 (treatment day)
* Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.
* Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)
* Tumor response is assessed every 2 cycles (6 weeks)
* Treatment is repeated until,.
* 4 cycles
* progressive disease
* unacceptable toxicity
* patient's withdrawal
* Gastric surgery should be performed within 4\~6 weeks of the last dose of chemotherapy
* Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
* Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.
* Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.
* Follow up for survival is repeated every 3 months for 2 years
Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months
Study Oversight
Has Oversight DMC:
True
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?: