Stomach Neoplasms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERQuality of life assessment
Quality of life and chemotherapy induced neurotoxicity evaluation
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life deterioration > 10% (dichotomic) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time to event considering the a drop of 10% in the sensory sub scale of the EORTC CIPN 20 Questionnaire |
| Disease free survival | Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months | Time to event |
| Overall survival | Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months | Time to event |
| 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 | Time to event considering the a drop of 10% in the global health sub scale of the EORTC C30 Questionnaire |
| 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 | Questionnaire EORTC C30 |
| 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 | Questionnaire EORTC CIPN20 |
| 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 | Questionnaire EORTC CIPN20 (sensory sub scale) in two consecutive evaluation |
Countries
Chile
Outcome results
None listed