Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
1 other identifier
observational
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 6, 2015
CompletedFirst Posted
Study publicly available on registry
October 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 7, 2017
March 1, 2017
1.8 years
September 6, 2015
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Disease free survival
Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
Overall survival
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)
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
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
Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
- +2 more secondary outcomes
Interventions
Quality of life and chemotherapy induced neurotoxicity evaluation
Eligibility Criteria
Patients with histological diagnosis of gastric adenocarcinoma who were treated with surgery
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Sótero del Río Hospital
Santiago, Chile
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastián Mondaca, MD
Pontificia Universidad Catolica de Chile
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2015
First Posted
October 16, 2015
Study Start
April 1, 2015
Primary Completion
January 1, 2017
Study Completion
June 1, 2018
Last Updated
March 7, 2017
Record last verified: 2017-03