Stomach NeoplasmsNCT02577263
Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
An observational study of Stomach Neoplasms, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Quality of life assessment
- How many people
- 64 participants
- Where
- 1 siteChile
- Study dates
- Apr 2015to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histological diagnosis of gastric adenocarcinoma who were treated with surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stomach Neoplasms
- Being tested
- Quality of life assessment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessmentOther
Quality of life and chemotherapy induced neurotoxicity evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life deterioration > 10% (dichotomic)
Questionnaire EORTC C30 (sub scale global health status) in two consecutive evaluation
Measured: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
Secondary outcomes (7)
Disease free survival
Time to event
Measured: Participants will be followed until 2 years after the end of chemotherapy for this outcome, an expected average of 24 months
Overall survival
Time to event
Measured: 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)
Questionnaire EORTC CIPN20 (sensory sub scale) in two consecutive evaluation
Measured: 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
Questionnaire EORTC C30
Measured: 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
Questionnaire EORTC CIPN20
Measured: 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 to event considering the a drop of 10% in the global health sub scale of the EORTC C30 Questionnaire
Measured: 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 to event considering the a drop of 10% in the sensory sub scale of the EORTC CIPN 20 Questionnaire
Measured: Participants will be followed until 3 months after the end of chemotherapy for this outcome, an expected average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastián Mondaca, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577263
- Sponsor's protocol ID
- 019892
- Status last verified
- Mar 2017
- First submitted
- 6 Sep 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02577263
- Acronym / sponsor ID
- 019892
- Conditions
- Stomach Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histological diagnosis of gastric adenocarcinoma who were treated with surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life assessmentQuality of life and chemotherapy induced neurotoxicity evaluation | Other | – |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastián Mondaca, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.