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

March 6, 2017 updated by: Pontificia Universidad Catolica de Chile
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Dr. Sótero del Río Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histological diagnosis of gastric adenocarcinoma who were treated with surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life deterioration > 10% (dichotomic)
Time Frame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
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 Frame: Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
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 Frame: Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
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)
Time Frame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
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
Time Frame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
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
Time Frame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
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 Frame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
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 Frame: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Sebastián Mondaca, MD, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

September 6, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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