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:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT01876927
Brief Summary:
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
Detailed Description:
Title: A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer.
Clinical Phase: II
Study Objectives:
Primary:
The percentage of patients receiving all the planned chemotherapeutic cycles.
Secondary:
* Downstaging according to Recist criteria
* pT1-3 vs pT0.
* Safety: number of patients with grade 3-4 toxicity
* The role of PET Scan as predictor of response
* Curative vs palliative surgery
* TTP
* OS
* Diagnostic correlation between the various staging methods
* Possible correlations between CT scan, CT/PET, laparoscopy;
* Molecular markers related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1;
* Molecular markers related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT);
* Molecular markers related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH.
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
Study:
NCT01876927
Study Brief:
Protocol Section:
NCT01876927