PRODIGE 34 - ADAGE: Randomised phase III study evaluating adjuvant chemotherapy after resection of stage III colon adenocarcinoma in patients aged 70 and older
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 973
- 试验地点
- 2
- 主要终点
- The primary endpoint is relapse-free survival (RFS). It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment.
研究概览
简要总结
To compare the relapse-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of patients aged 70 and over after a stage III upper rectal or colon cancer resection.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Effective contraception for male patients throughout the treatment and at least 6 months after stopping the oxaliplatin treatment
- •Informed consent(s) signed
- •Patient deemed fit by the MCM to receive chemotherapy
- •Lee’s score (Appendix 1) examined and faxed to the RMAC
- •Stage III upper rectal or colon adenocarcinoma
- •Resection R0 of the primary tumour
- •Start of the adjuvant chemotherapy possible within 12 weeks after the surgery
- •No prior chemotherapy for colon cancer
- •Initial geriatric “patient” self-questionnaire completed and faxed to the RMAC (Appendix 2)
- •Initial geriatric “team” questionnaire completed and faxed to the RMAC (Appendix 3)
排除标准
- •Another progressive malignant tumour (cancer not stabilised since less than 2 years)
- •Rectal cancer (localised at less than 10 cm from the anal margin by endoscopy or sub-peritoneal)
- •PMNs < 2,000/mm3 for group 1 and PMNs < 1,500/mm3 for group 2, platelets < 100,000/mm3 or haemoglobin < 9 g/dL
- •Neuropathy for the patients from group 1
- •Known total or partial dihydropyrimidine dehydrogenase (DPD) deficiency
- •Patient with severe liver insufficiency
- •Any contra-indication to the medicinal products used in the study (refer to the updated versions of the SPCs of the products used, in Appendix 8)
- •Impossibility to undergo the trial's medical follow-up for geographical, social, or psychological reasons
结局指标
主要结局
The primary endpoint is relapse-free survival (RFS). It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment.
The primary endpoint is relapse-free survival (RFS). It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment.
次要结局
- The time to decrease in the quality of life
- Overall survival
- The time to decrease in autonomy
- The dose intensity
- The overall tolerance to the treatments
- The time to recurrence
研究者
coordonator
Scientific
Fondation Franc.Cancerologie Digestive