Trials / Unknown
UnknownNCT02577263
Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 64 (actual)
- Sponsor
- Pontificia Universidad Catolica de Chile · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Quality of life assessment | Quality of life and chemotherapy induced neurotoxicity evaluation |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-01-01
- Completion
- 2018-06-01
- First posted
- 2015-10-16
- Last updated
- 2017-03-07
Locations
1 site across 1 country: Chile
Source: ClinicalTrials.gov record NCT02577263. Inclusion in this directory is not an endorsement.