Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01286766
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
Study:
NCT01286766
Study Brief:
Protocol Section:
NCT01286766