BRCA Gene RearrangementNCT03838406
BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer
A study testing BRCA 1 and Chemotherapy in people with BRCA Gene Rearrangement, run by Chung-Ang University at 1 site in South Korea.
Trial summary
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- BRCA Gene Rearrangement
- What is being tested?
- BRCA 1 and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic gastric cancer( Adenocarcinoma)
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- one more measure lesion
- White blood cell count (WBC) > 3000/ul , Platelet > 75,000/ul
- Normal kidney function (serum creatinine < 1.5 ULN)
- Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 3 times of upper normal limit, if liver metastasis, AST/ALT < 5 times of upper normal limit)
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- life expectancy is more than 3 months
- Conventional surgery that does not cause the transformation of the target lesion is allowed
- The patient who voluntarily decided to participate in this study and agreed in writing
Who cannot join
- Her-2 positive advanced gastric cancer
- Central nervous system metastases requiring treatment with symptoms
- Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months)
- Uncontrolled infection or other serious diseases
- Patients with serious medical conditions or serious illnesses
- Patient who is pregnant or lactating
- Adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register)
- In the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
Read the detailed description
Stomach cancer is still the leading cause of cancer deaths globally and is reported to be the second leading cause of cancer deaths in Korea (18.7%). Although the number of radical resection has increased due to the development of early diagnosis, many patients experience recurrence after radical resection. It is also diagnosed as a non - resectable disease locally advanced at the time of initial diagnosis, or with a metastasis. In patients with recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine (fluorouracil, capecitabine, S1) and platinum (oxaliplatin, cisplatin). The progression-free survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer patients.
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
- Conditions
- BRCA Gene Rearrangement
- Being tested
- BRCA 1, Chemotherapy
- Keywords
- Stomach cancer, Chemotherapy, FOLFOX, Capecitabine plus Oxalipatin (CAPOX)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRCA 1Genetic
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.
ChemotherapyDrug
Also called FOLFOX or CAPOX
FOLFOX :
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
CAPOX:
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| BRCA1 positive | Experimental | FOLFOX or CAPOX Chemotherapy
FOLFOX :
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
CAPOX:
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days. Receives: Genetic: BRCA 1; Drug: Chemotherapy |
| BRCA1 negative | Active comparator | FOLFOX or CAPOX Chemotherapy
FOLFOX :
Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
CAPOX:
Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days. Receives: Genetic: BRCA 1; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Progression free survival
the time from diagnosis to death by any cause and progression.
Measured: through study completion, an average of 1 year
Overall survival
the time from diagnosis to death by any cause
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA Gene RearrangementStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Hwang, Chung-Ang University
- Investigators
- In Gyu Hwang, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838406
- Sponsor's protocol ID
- 1771-001-287
- Status last verified
- Jan 2021
- First submitted
- 7 Feb 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT03838406
- Acronym / sponsor ID
- 1771-001-287
- Conditions
- BRCA Gene Rearrangement
- Keywords
- Stomach cancer, Chemotherapy, FOLFOX, Capecitabine plus Oxalipatin (CAPOX)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Feb 2019 (actual)
- 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 investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
Detailed description
Stomach cancer is still the leading cause of cancer deaths globally and is reported to be the second leading cause of cancer deaths in Korea (18.7%). Although the number of radical resection has increased due to the development of early diagnosis, many patients experience recurrence after radical resection. It is also diagnosed as a non - resectable disease locally advanced at the time of initial diagnosis, or with a metastasis. In patients with recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine (fluorouracil, capecitabine, S1) and platinum (oxaliplatin, cisplatin). The progression-free survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer patients.
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRCA1 positive | Experimental | Genetic: BRCA 1, Drug: ChemotherapyFOLFOX or CAPOX Chemotherapy FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days. |
| BRCA1 negative | Active comparator | Genetic: BRCA 1, Drug: ChemotherapyFOLFOX or CAPOX Chemotherapy FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic gastric cancer( Adenocarcinoma)
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- one more measure lesion
- White blood cell count (WBC) > 3000/ul , Platelet > 75,000/ul
- Normal kidney function (serum creatinine < 1.5 ULN)
Key exclusion criteria (8 listed)
- Her-2 positive advanced gastric cancer
- Central nervous system metastases requiring treatment with symptoms
- Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months)
- Uncontrolled infection or other serious diseases
- Patients with serious medical conditions or serious illnesses
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 |
|---|---|---|
| BRCA 1The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis. | Genetic | BRCA1 negative, BRCA1 positive |
| ChemotherapyAlso: FOLFOX or CAPOXFOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days. | Drug | BRCA1 negative, BRCA1 positive |
Primary outcome
Objective response rate
Time frame: through study completion, an average of 1 year
the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.
2 secondary outcomes
Progression free survival
Time frame: through study completion, an average of 1 year
Overall survival
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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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.
In Gyu Hwang principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRCA 1 and Chemotherapy in people with BRCA Gene Rearrangement, run by Chung-Ang University at 1 site in South Korea.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (time frame: through study completion, an average of 1 year). 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 27 Jan 2021.