Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Other: Quality of life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quality of life assessment|Quality of life and chemotherapy induced neurotoxicity evaluation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life deterioration > 10% (dichotomic) | Questionnaire EORTC C30 (sub scale global health status) in two consecutive evaluation | Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Time to event | Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months | 
| Overall survival | Time to event | Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months | 
| Significant chemotherapy induced neurotoxicity > 10% (dichotomic) | Questionnaire EORTC CIPN20 (sensory sub scale) in two consecutive evaluation | 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 | Questionnaire EORTC C30 | 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 | Questionnaire EORTC CIPN20 | Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months | 
| Quality of life deterioration > 10% | Time to event considering the a drop of 10% in the global health sub scale of the EORTC C30 Questionnaire | 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% | Time to event considering the a drop of 10% in the sensory sub scale of the EORTC CIPN 20 Questionnaire | Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months |