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

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ClinicalTrials.gov Identifier: NCT02577263
Recruitment Status : Unknown
Verified March 2017 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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.

Condition or disease Intervention/treatment
Stomach Neoplasms Other: Quality of life assessment

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.

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer


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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histological diagnosis of gastric adenocarcinoma who were treated with surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577263


Locations
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Chile
Dr. Sótero del Río Hospital
Santiago, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Sebastián Mondaca, MD Pontificia Universidad Catolica de Chile
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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02577263    
Other Study ID Numbers: 019892
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Stomach Neoplasms
Neurotoxicity Syndromes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders