Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Quality of life deterioration > 10% (dichotomic)
研究概览
简要总结
The primary objective of this trial is to determine the impact of the FOLFOX regimen on quality of life and the incidence of chemotherapy induced neurotoxicity.
详细描述
Gastric cancer is one of the main cancer-related causes of death in the world. There is more than one standard treatment for non-metastatic advanced disease. Among the therapeutic alternatives there is high level of evidence to recommend surgery followed by chemoradiotherapy or chemotherapy and for perioperative chemotherapy. These strategies have not been compared in adequate powered trials, so there are important regional differences in their use. Postoperative chemotherapy with oxaliplatin based chemotherapy may offer some advantages in limited resource settings, because of its lower logistic requirements and it could be specially useful in centers with high quality surgery. On the other hand one of its most important downsides could be a higher impact on quality of life particularly related to oxaliplatin induced neuropathy which can last long after the end of treatment. This is a prospective observational trial in which after consent subjects are going to be evaluated with the EORTC (European Organization for Research and Treatment of Cancer) questionnaires C30 and CIPN20 during FOLFOX (5-fluorouracil/leucovorin with oxaliplatin) adjuvant treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gastric adenocarcinoma
- •ECOG (Eastern Cooperative Oncology Group) functional status of 0 or 1
- •Treated with surgery with curative intent
- •TNM stage II - III or TNM stage I with positives lymph nodes
排除标准
- •Surgery with microscopical or macroscopical residual tumour
- •Adjuvant chemotherapy refusal
- •ECOG functional status of 2 or more
- •Previous peripheral neuropathy
- •Significant cardiovascular disease or other organ disfunction
结局指标
主要结局
Quality of life deterioration > 10% (dichotomic)
时间窗: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
Questionnaire EORTC C30 (sub scale global health status) in two consecutive evaluation
次要结局
- Significant chemotherapy induced neurotoxicity > 10% (dichotomic)(Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months)
- Significant chemotherapy induced neurotoxicity > 10%(Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months)
- Median change in Quality of life score(Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months)
- Median change in chemotherapy induced neurotoxicity score(Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months)
- Disease free survival(Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months)
- Quality of life deterioration > 10%(Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months)
- Overall survival(Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months)