Locally Advanced Unresectable Esophageal CancerPhase 2NCT06598917
Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRT
A Phase 2 study testing S-1 in people with Locally Advanced Unresectable Esophageal Cancer, run by China Medical University Hospital.
Trial summary
Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer. Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Locally Advanced Unresectable Esophageal Cancer
- What is being tested?
- S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Oct 2028
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an age of at least 20 years;
- patients with histologically confirmed diagnosis of ESCC (Esophageal squamous cell carcinoma), GEJC (gastroesophageal junction cancer), EAC (Esophageal adenocarcinoma)
- stage II-IVA, AJCC, 8th, locally advanced disease is suitable for dCCRT and is ineligible for curative surgery (including those who are unable or unwilling to undergo surgery)
- an Eastern Cooperative Oncology Group performance-status score of 0-1
- definitive concurrent chemoradiotherapy according to regional oncology guidelines for esophageal cancer, with the following criteria:
- patients must have received platinum-based chemotherapy (at least 2 cycles of tri-weekly regimen or at least 4 cycles of weekly regimen) and radiation therapy consistent with definitive treatment (50-64 Gy)
- no evidence of radiographic disease progression per RECIST v1.1, as documented by comparison of scans (pre- and post-definitive concurrent chemoradiotherapy) prior to enrollment.
- adequate bone marrow, hepatic, renal and cardiac function
Who cannot join
- patients had distant metastasis
- patients had esophageal perforation or esophageal fistula
- patients had tumor bleeding
- patients had severe infection
- History of malignancy other than esophageal cancer within 2 years prior to screening
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: Phase II Study of Maintenance Chemotherapy With S-1 in Patients With Locally Advanced Esophageal Cancer Receiving Definitive Concurrent Chemoradiotherapy
Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer.
Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT.
Read more
The aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1.
The primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.
Read the detailed description
Esophageal cancer is an aggressive malignant disease, ranking seventh in incidence and sixth in mortality among all cancers. The lack of a serosa layer in the esophagus allows tumor regional spread to nearby organs and lymph nodes. While radical surgery was historically the preferred treatment for esophageal cancer, 50% to 60% of patients are deemed unsuitable for surgical resection at diagnosis due to being in an advanced stage of the disease. Definitive chemo-radiotherapy (dCCRT), combining platinum-based chemotherapy with taxanes or fluoropyrimidine, is the standard treatment for unresectable locally advanced ESCC. Despite this, survival outcomes with the current dCCRT standard are suboptimal, and nearly all patients ultimately experience tumor progression.
Intensifying treatment by applying consolidative chemotherapy (CCT) after dCCRT may, in theory, enhance outcomes for these patients. A Systematic Review and Meta-Analysis report short-time survival benefit of additional CCT compared to CCRT alone for patients with unresectable esophageal cancer. The CCRT-CCT group could significantly reduce the risk of distant metastases and improved 3-year OS rate, comparing with CCRT alone. Another population-based cohort study also showed that CCT was associated with significantly improved OS for locally advanced ESCC patients treated with dCCRT.
As an oral fluoropyrimidine, Golfer is designed to have enhanced anticancer activity and reduced toxicity10. In the large phase 3 randomized clinical trial, CRT with was tolerable and provided significant benefits over RT alone in older patients with esophageal cancer. In another similar study of radiotherapy concurrent with and followed by oral S-1 chemotherapy concurrent S-1 improved survival outcomes without additional treatment related toxic effects. In this trial consolidated S-1 administrated a total of 4 cycles. The maintenance chemotherapy using S-1(MC-S1) in patients with N3 stage nasopharyngeal carcinoma achieved superior survival. The MC-S1 was administered for at least 12 cycles. The toxicities of MC-S1 were mild and tolerable.
However, whether or not dCCRT follow maintenance therapy with S-1 improve the survival outcomes of patients with locally advanced unresectable esophageal cancer are unclear. Therefore, the aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1. The primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.
- Being tested
- S-1
- Keywords
- consolidative chemotherapy, esophageal squamous cell carcinoma, S1
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Treatment schedule At 4 to 8 weeks after chemotherapy and radiotherapy ended, maintenance S-1 was administered for up to 12 cycles. A cycle was 3 weeks, with S-1 administrated on days 1 to 14 in each cycle.
The initial dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA \< 1.25 m2; 50 mg twice a day for 1.25 m2⩽ BSA \< 1.5 m2; and 60 mg twice a day for BSA ⩾1.5 m2.
Maintenance chemotherapy with S1 was administered for 12 cycles or terminated earlier if there was disease progression, intolerable toxicity, or at the patient's request.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance chemotherapy with S-1 regimen | Experimental | Maintenance chemotherapy with S-1 regimen Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable Esophageal CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yu Lien, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598917
- Sponsor's protocol ID
- CMUH113-REC3-106 CHEERS
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Maintenance Chemotherapy With S-1 in Patients With Locally Advanced Esophageal Cancer Receiving Definitive Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT06598917
- Acronym / sponsor ID
- CMUH113-REC3-106 CHEERS
- Keywords
- consolidative chemotherapy, esophageal squamous cell carcinoma, S1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer.
Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT.
The aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1.
The primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.
Detailed description
Esophageal cancer is an aggressive malignant disease, ranking seventh in incidence and sixth in mortality among all cancers. The lack of a serosa layer in the esophagus allows tumor regional spread to nearby organs and lymph nodes. While radical surgery was historically the preferred treatment for esophageal cancer, 50% to 60% of patients are deemed unsuitable for surgical resection at diagnosis due to being in an advanced stage of the disease. Definitive chemo-radiotherapy (dCCRT), combining platinum-based chemotherapy with taxanes or fluoropyrimidine, is the standard treatment for unresectable locally advanced ESCC. Despite this, survival outcomes with the current dCCRT standard are suboptimal, and nearly all patients ultimately experience tumor progression.
Intensifying treatment by applying consolidative chemotherapy (CCT) after dCCRT may, in theory, enhance outcomes for these patients. A Systematic Review and Meta-Analysis report short-time survival benefit of additional CCT compared to CCRT alone for patients with unresectable esophageal cancer. The CCRT-CCT group could significantly reduce the risk of distant metastases and improved 3-year OS rate, comparing with CCRT alone. Another population-based cohort study also showed that CCT was associated with significantly improved OS for locally advanced ESCC patients treated with dCCRT.
As an oral fluoropyrimidine, Golfer is designed to have enhanced anticancer activity and reduced toxicity10. In the large phase 3 randomized clinical trial, CRT with was tolerable and provided significant benefits over RT alone in older patients with esophageal cancer. In another similar study of radiotherapy concurrent with and followed by oral S-1 chemotherapy concurrent S-1 improved survival outcomes without additional treatment related toxic effects. In this trial consolidated S-1 administrated a total of 4 cycles. The maintenance chemotherapy using S-1(MC-S1) in patients with N3 stage nasopharyngeal carcinoma achieved superior survival. The MC-S1 was administered for at least 12 cycles. The toxicities of MC-S1 were mild and tolerable.
However, whether or not dCCRT follow maintenance therapy with S-1 improve the survival outcomes of patients with locally advanced unresectable esophageal cancer are unclear. Therefore, the aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1. The primary endpoint is overall survival (OS) rates at 24 months, defined as the proportion of patients who have not experienced death from any cause at months. With a sample size of 60 patients, the study had a power of 80%, assuming 2-year OS of 45% in the experimental arm and 30% in the historical control, with a one-sided significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance chemotherapy with S-1 regimen | Experimental | Drug: S-1Maintenance chemotherapy with S-1 regimen |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- an age of at least 20 years;
- patients with histologically confirmed diagnosis of ESCC (Esophageal squamous cell carcinoma), GEJC (gastroesophageal junction cancer), EAC (Esophageal adenocarcinoma)
- stage II-IVA, AJCC, 8th, locally advanced disease is suitable for dCCRT and is ineligible for curative surgery (including those who are unable or unwilling to undergo surgery)
- an Eastern Cooperative Oncology Group performance-status score of 0-1
- definitive concurrent chemoradiotherapy according to regional oncology guidelines for esophageal cancer, with the following criteria:
Key exclusion criteria (5 listed)
- patients had distant metastasis
- patients had esophageal perforation or esophageal fistula
- patients had tumor bleeding
- patients had severe infection
- History of malignancy other than esophageal cancer within 2 years prior to screening
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 |
|---|---|---|
| S-1Treatment schedule At 4 to 8 weeks after chemotherapy and radiotherapy ended, maintenance S-1 was administered for up to 12 cycles. A cycle was 3 weeks, with S-1 administrated on days 1 to 14 in each cycle. The initial dose of S-1 was determined according to the body surface area (BSA): 40 mg twice a day for BSA \< 1.25 m2; 50 mg twice a day for 1.25 m2⩽ BSA \< 1.5 m2; and 60 mg twice a day for BSA ⩾1.5 m2. Maintenance chemotherapy with S1 was administered for 12 cycles or terminated earlier if there was disease progression, intolerable toxicity, or at the patient's request. | Drug | Maintenance chemotherapy with S-1 regimen |
Primary outcome
overall survival (OS)
Time frame: 24 months
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 19 Sep 2024.
- 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 2 study testing S-1 in people with Locally Advanced Unresectable Esophageal Cancer, run by China Medical University Hospital.
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 8 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ming-Yu LIen, M.D. Ph.D. (8864+22052121, leinmirain@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 24 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 19 Sep 2024.