Clinical trial NCT02577263: Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
Official title: Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histological diagnosis of gastric adenocarcinoma who were treated with surgery

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
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
measure: Significant chemotherapy induced neurotoxicity > 10% (dichotomic)
timeFrame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
measure: Median change in Quality of life score
timeFrame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
measure: Median change in chemotherapy induced neurotoxicity score
timeFrame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
measure: Quality of life deterioration > 10%
timeFrame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
measure: Significant chemotherapy induced neurotoxicity > 10%
timeFrame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Dr. Sótero del Río Hospital
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Sebastián Mondaca, MD
role: PRINCIPAL_INVESTIGATOR
References: