Esophagogastric Junction DisorderPhase 3NCT03961841
Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma
A Phase 3 study testing chemoradiation with weekly 5Fu and oxaliplatin, Perioperative mFLOT and Perioperative FOLFOX in people with Esophagogastric Junction Disorder and Neoplasms, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagogastric Junction Disorder, Neoplasms
- What is being tested?
- chemoradiation with weekly 5Fu and oxaliplatin, Perioperative mFLOT and Perioperative FOLFOX
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consensus of the enrolled patients
- from 18 to 75 years old
- proven to be primary adenocarcinoma of EGJ
- pre-operative staging cT3-4N+M0
- no prior other chemotherapy and/or radiation against the disease
- normal function of all other vital organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status: 0~2
Who cannot join
- history of other malignancy
- allergic reaction to capecitabine or oxaliplatin
- enrolled in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
- other situations judged as not adaptive to the study by investigators
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
- Conditions
- Esophagogastric Junction Disorder, Neoplasms
- Being tested
- chemoradiation with weekly 5Fu and oxaliplatin, Perioperative mFLOT, Perioperative FOLFOX
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiation with weekly 5Fu and oxaliplatinRadiation
5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week
Perioperative mFLOTDrug
Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
Perioperative FOLFOXDrug
Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation | Active comparator | weekly 5-Fu and oxaliplatin Receives: Radiation: chemoradiation with weekly 5Fu and oxaliplatin |
| FLOT | Experimental | Eight perioperative chemotherapy cycles Receives: Drug: Perioperative mFLOT |
| FOLFOX | Experimental | Twelve perioperative chemotherapy cycles Receives: Drug: Perioperative FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year of disease free survival
Measured: 3 year
Secondary outcomes (3)
5 year of overall survival
Measured: 5 year
Rate of pathological complete remission
Measured: 1 year
Anastomosis leak rate
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 posted23 May 2019
- Study startJun 2020 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric Junction DisorderStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961841
- Sponsor's protocol ID
- SAHMO202
- Status last verified
- Dec 2019
- First submitted
- 22 May 2019
- Last updated
- 23 Dec 2019
- 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 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03961841
- Acronym / sponsor ID
- SAHMO202
- Conditions
- Esophagogastric Junction Disorder, Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 23 May 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.
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation | Active comparator | Radiation: chemoradiation with weekly 5Fu and oxaliplatinweekly 5-Fu and oxaliplatin |
| FLOT | Experimental | Drug: Perioperative mFLOTEight perioperative chemotherapy cycles |
| FOLFOX | Experimental | Drug: Perioperative FOLFOXTwelve perioperative chemotherapy cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- informed consensus of the enrolled patients
- from 18 to 75 years old
- proven to be primary adenocarcinoma of EGJ
- pre-operative staging cT3-4N+M0
- no prior other chemotherapy and/or radiation against the disease
Key exclusion criteria (7 listed)
- history of other malignancy
- allergic reaction to capecitabine or oxaliplatin
- enrolled in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
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 |
|---|---|---|
| chemoradiation with weekly 5Fu and oxaliplatin5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week | Radiation | Chemoradiation |
| Perioperative mFLOTPerioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles | Drug | FLOT |
| Perioperative FOLFOXPerioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles | Drug | FOLFOX |
Primary outcome
3 year of disease free survival
Time frame: 3 year
3 secondary outcomes
5 year of overall survival
Time frame: 5 year
Rate of pathological complete remission
Time frame: 1 year
Anastomosis leak rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chemoradiation with weekly 5Fu and oxaliplatin, Perioperative mFLOT and Perioperative FOLFOX in people with Esophagogastric Junction Disorder and Neoplasms, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 7 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: opening soon, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Li, MD (86-20-38285497, lishsh89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year of disease free survival (time frame: 3 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 23 Dec 2019.