SMALL BOWEL ADENOCARCINOMA
Conditions
Brief summary
Disease-free survival (DFS) is the primary endpoint of the study. It is defined as the time from randomisation to the first occurrence of the following events: - Recurrence of disease (confirmed by imaging) - Development of a new primary tumour (confirmed by imaging and histology/cytology) - Death Patients who do not present any of these events will be censored at the date of last news.
Detailed description
Overall survival: the survival status of patients will be determined at each follow-up visit., Chemotherapy toxicity: toxicity will be assessed using the CTCAE version 4.0 classification. Only toxicities of at least grade 2 will be recorded in the CRF., Quality of life: this will be assessed using the EORTC QLQ-C30, EORTC QLQ-CR29 and EQ-5D questionnaires., Health economics: to assess the cost-effectiveness of 24 weeks of adjuvant chemotherapy compared with observation alone, and of 24 weeks of adjuvant 5-FU/capecitabine monotherapy compared with 5-FU/capecitabine plus oxaliplatin. The results will be reported in terms of incremental cost per DFS and incremental cost per QALY.
Interventions
DRUGFOLINIC ACID
DRUGCAPECITABINE
DRUGFLUOROURACIL
DRUGOXALIPLATIN
Sponsors
Centre Hospitalier Universitaire De Dijon
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) is the primary endpoint of the study. It is defined as the time from randomisation to the first occurrence of the following events: - Recurrence of disease (confirmed by imaging) - Development of a new primary tumour (confirmed by imaging and histology/cytology) - Death Patients who do not present any of these events will be censored at the date of last news. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival: the survival status of patients will be determined at each follow-up visit., Chemotherapy toxicity: toxicity will be assessed using the CTCAE version 4.0 classification. Only toxicities of at least grade 2 will be recorded in the CRF., Quality of life: this will be assessed using the EORTC QLQ-C30, EORTC QLQ-CR29 and EQ-5D questionnaires., Health economics: to assess the cost-effectiveness of 24 weeks of adjuvant chemotherapy compared with observation alone, and of 24 weeks of adjuvant 5-FU/capecitabine monotherapy compared with 5-FU/capecitabine plus oxaliplatin. The results will be reported in terms of incremental cost per DFS and incremental cost per QALY. | — |
Countries
France
Outcome results
None listed