Esophageal CancermEGANCT02358863
Molecularly Tailored Therapy for Patients With Metastatic Cancer of the Esophagus and Stomach
A study testing Modified FOLFOX6, Docetaxel/Capecitabine and Cisplatin/Irinotecan in people with Esophageal Cancer and Gastric Cancer, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Modified FOLFOX6, Docetaxel/Capecitabine and Cisplatin/Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
- Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
- Patients who are not eligible for resection and are chemotherapy naïve
- Patients with HER2(-) status
- Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
- Patients must have adequate organ function
- Patients must provide written informed consent
Who cannot join
- Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
- ECOG performance status worse than 2
- Prior oral or intravenous chemotherapy for metastatic disease
- Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
- cardiac ejection fraction 45% or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Modified FOLFOX6, Docetaxel/Capecitabine, Cisplatin/Irinotecan, Cisplatin/Docetaxel, IRI/EPI
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified FOLFOX6Drug
Also called Oxaliplatin, Eloxatin, Leucovorin, 5-FU
Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1
Docetaxel/CapecitabineDrug
Also called Taxotere, Xeloda
Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14
Cisplatin/IrinotecanDrug
Also called Platinum, CPT-11, Camptosar
Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days
Cisplatin/DocetaxelDrug
Also called Platinum, Taxotere
Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
IRI/EPIDrug
Also called Irinotecan, CPT-11, Epirubicin, Camptosar
Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days
EPI/DocetaxelDrug
Also called Taxotere, Epirubicin
Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2
Irinotecan/DocetaxelDrug
Also called CPT-11, Camptosar, Taxotere
Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1
DocetaxelDrug
Also called Taxotere
Docetaxel 60-100 mg/m2 IV day 1 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Standard chemotherapy doublet based on molecular testing using one of the following interventions:
Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel Receives: Drug: Modified FOLFOX6; Drug: Docetaxel/Capecitabine; Drug: Cisplatin/Irinotecan; Drug: Cisplatin/Docetaxel; Drug: IRI/EPI; Drug: EPI/Docetaxel; Drug: Irinotecan/Docetaxel; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients With Tumor Size Reduction (Objective Response Rate)
Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Issues with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Marshall, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358863
- Sponsor's protocol ID
- 2013-0973
- Acronym
- mEGA
- Status last verified
- Aug 2017
- First submitted
- 4 Feb 2015
- Last updated
- 6 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Molecular Profile-Directed Chemotherapy for Metastatic HER2(-) Esophagogastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02358863
- Acronym / sponsor ID
- mEGA / 2013-0973
- Conditions
- Esophageal Cancer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with recruitment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Modified FOLFOX6, Drug: Docetaxel/Capecitabine, Drug: Cisplatin/Irinotecan, Drug: Cisplatin/Docetaxel, Drug: IRI/EPI, Drug: EPI/Docetaxel, Drug: Irinotecan/Docetaxel, Drug: DocetaxelStandard chemotherapy doublet based on molecular testing using one of the following interventions: Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Advanced, measurable metastatic esophagogastric adenocarcinoma by RECIST criteria
- Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
- Patients who are not eligible for resection and are chemotherapy naïve
- Patients with HER2(-) status
- Patients who have tumor deposit(s) that are easily accessible by ultrasound or CT guidance
Key exclusion criteria (5 listed)
- Active concurrent malignancy, other than superficial, non-squamous cell carcinoma of the skin or uterine cervix, within the past three years
- ECOG performance status worse than 2
- Prior oral or intravenous chemotherapy for metastatic disease
- Patients with comorbidities that prevent them from being able to receive the chemotherapy regimen
- cardiac ejection fraction 45% or greater
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 |
|---|---|---|
| Modified FOLFOX6Also: Oxaliplatin, Eloxatin, Leucovorin, 5-FUOxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1 | Drug | Chemotherapy |
| Docetaxel/CapecitabineAlso: Taxotere, XelodaDocetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14 | Drug | Chemotherapy |
| Cisplatin/IrinotecanAlso: Platinum, CPT-11, CamptosarCisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days | Drug | Chemotherapy |
| Cisplatin/DocetaxelAlso: Platinum, TaxotereCisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1 | Drug | Chemotherapy |
| IRI/EPIAlso: Irinotecan, CPT-11, Epirubicin, CamptosarIrinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days | Drug | Chemotherapy |
| EPI/DocetaxelAlso: Taxotere, EpirubicinDocetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2 | Drug | Chemotherapy |
| Irinotecan/DocetaxelAlso: CPT-11, Camptosar, TaxotereIrinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1 | Drug | Chemotherapy |
| DocetaxelAlso: TaxotereDocetaxel 60-100 mg/m2 IV day 1 every 21 days | Drug | Chemotherapy |
Primary outcome
The Number of Patients With Tumor Size Reduction (Objective Response Rate)
Time frame: 1 year
Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Marshall, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified FOLFOX6, Docetaxel/Capecitabine and Cisplatin/Irinotecan in people with Esophageal Cancer and Gastric Cancer, run by Georgetown University at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 6 Sep 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Patients With Tumor Size Reduction (Objective Response Rate) (time frame: 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 6 Sep 2018.