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The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and FOLFPTX as first-line treatment in AGC or EGJA.
In previous studies, we found that mFOLFOX(a Combination of Oxaliplatin, Fluorouracil), mFOLFIRI(a Combination of Irinotecan, Fluorouracil), FOLFPTX (a Combination of Paclitaxel, Fluorouracil) are active in patients with AGC or EGJA.This study is being done to find out which one has the best efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFOX | Experimental | The mFOLFOX regimen consisted of oxaliplatin (85 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities. |
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| mFOLFIRI | Experimental | The mFOLFIRI regimen consisted of irinotecan (180 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities. |
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| FOLFPTX | Experimental | The FOLFPTX regimen consisted of paclitaxel (95 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil | Drug | Fluorouracil was used as first line treatment with AGC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 24 months | |
| Adverse Event(AE) | NCI CTC 4.03 | 35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 24 months | |
| Disease Control Rate (DCR) | 24 months | |
| Overall Survival (OS) |
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Inclusion Criteria:
Age:18~70years.
Subjects with Histologically or cytologically confirmed advanced or metastatic gastric cancer or adenocarcinoma of gastroesophageal junction.
First-line treatment patients.
subjects with at least one measurable lesion as defined by RECIST (version 1.1).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Survival expectation≥ 3 months.
No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on ).
Adequate organ functions defined as indicated below: (1)Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianwei Yang | Contact | 008613805097959 | swzcq62@163.com | |
| Sha Huang | Contact | 008613763820570 | huangsha0210@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianwei Yang | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianwei Yang | Fuzhou | Fujian | 350000 | China |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Oxaliplatin | Drug | Oxaliplatin was used as first line treatment with AGC. |
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| Irinotecan | Drug | Irinotecan was used as first line treatment with AGC. |
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| Paclitaxel | Drug | Paclitaxel was used as first line treatment with AGC. |
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| calcium levofolinate | Drug | Calcium levofolinate was used as first line treatment with AGC. |
|
| 35 months |
| Quality of Life (QoL) | Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30]. | 35 months |
| D006571 |
| Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |