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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02577263
• Other study ID #: 019892
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2015
• Last updated: March 6, 2017
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: March 2017
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurotoxicity Syndromes
• Stomach Neoplasms

Intervention

Other:
• Quality of life assessment
Quality of life and chemotherapy induced neurotoxicity evaluation

Locations

Country	Name	City	State
Chile	Dr. Sótero del Río Hospital	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease free survival	Time to event	Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
Secondary	Overall survival	Time to event	Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
Secondary	Significant chemotherapy induced neurotoxicity > 10% (dichotomic)	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
Secondary	Median change in Quality of life score	Questionnaire EORTC C30	Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
Secondary	Median change in chemotherapy induced neurotoxicity score	Questionnaire EORTC CIPN20	Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
Secondary	Quality of life deterioration > 10%	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
Secondary	Significant chemotherapy induced neurotoxicity > 10%	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