Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer
Клучни зборови
Апстракт
Датуми
| Последен пат проверено: | 04/30/2019 |
| Прво доставено: | 12/19/2006 |
| Поднесено е проценето запишување: | 12/19/2006 |
| Прво објавено: | 12/20/2006 |
| Последното ажурирање е доставено: | 05/30/2019 |
| Последно ажурирање објавено: | 07/24/2019 |
| Датум на први доставени резултати: | 05/26/2016 |
| Датум на први доставени резултати за КК: | 05/30/2019 |
| Датум на објавување на првите резултати: | 07/24/2019 |
| Крај на датумот на започнување на студијата: | 12/31/2005 |
| Проценет датум на примарно завршување: | 09/30/2015 |
| Проценет датум на завршување на студијата: | 09/30/2015 |
Состојба или болест
Интервенција / третман
Drug: Docetaxel and Capecitabine in gastric cancer
Drug: Docetaxel and Capecitabine in gastric cancer
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Experimental: Docetaxel and Capecitabine in gastric cancer Intravenous docetaxel 60 mg/m2 on day 1 and oral capecitabine 900 mg/m2 two times per day from day 1 to day 14 every 3 weeks for 2 cycles. | Drug: Docetaxel and Capecitabine in gastric cancer Docetaxel 60 mg/m2 IV on day 1 |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: - Age greater than or equal 18 years. - Histologic or cytologic diagnosis of adenocarcinoma of stomach or gastric cardia (Siewert Classification Type III) - Preoperative Stage T3-4NxM0 by endoscopic ultrasound, CT of the abdomen/pelvis and laparoscopy. (CT of the chest if it is a cardia lesion). - Absence of malignant cells in peritoneal lavage fluid during laparoscopic examination. - Patients must not have received any prior chemotherapy or hormonal therapy for the treatment of gastric cancer. - Karnofsky performance status of 70 or higher. - Estimated life expectancy of at least 12 weeks. - Adequate organ function including the following: - Bone marrow: - White blood cells (WBC) greater than or equal 3.5 x 109/L - Absolute neutrophil (segmented and bands) count (ANC) greater than or equal 1.5 x 109/L - Platelets greater than or equal 100 x 109/L - Haemoglobin greater than or equal 9g/dL - Hepatic: - Bilirubin within upper limit of normal (ULN), - ALT or AST less than or equal 2.5x ULN - Alkaline phosphatase less than or equal 2.5x ULN. - Renal: - creatinine less than or equal 1.5x ULN - Signed informed consent by patient or legal representative. - Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. Exclusion Criteria: - Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic disease will render patient ineligible according to American Joint Committee on Cancer (AJCC) staging manual. (See appendix 11.4). - Treatment within the last 30 days with any investigational drug. - Concurrent administration of any other cancer therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. - Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. - Pregnancy. - Breast-feeding. - Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. - Poorly controlled diabetes mellitus with fasting blood sugar > 18 mmol/L(mM). - Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. - History of significant neurological or mental disorder, including seizures or dementia. - History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations. - History of hypersensitivity to 5-fluorouracil |
Исход
Мерки на примарниот исход
1. Number of Participants With Pathological Response [up to 5 years]
Секундарни мерки на исходот
1. Overall Survival [up to 8 years]
2. Progression-free Survival as Measured by Number of Participants Without Disease Progression. [up to 5 years]
3. Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE. [up to 5 years]
4. Correlation of CGH and Gene Expression Profile and Their Changes After Chemotherapy With the Same Clinical Outcomes [up to 5 years]
