Clinical trial · Observational
Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
NCT02577263CI-TRIAL-00026320unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of life assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quality of life deterioration > 10% (dichotomic)
- timeFrame
- Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
- description
- Questionnaire EORTC C30 (sub scale global health status) in two consecutive evaluation
Secondary outcomes (7)
- measure
- Disease free survival
- timeFrame
- Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
- description
- Time to event
- measure
- Overall survival
- timeFrame
- Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
- description
- Time to event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.