Esophageal CancerPhase 3NCT02813967
S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Patients With Esophageal Cancer
A Phase 3 study testing Radiotherapy 54 Gy, Radiotherapy 60 Gy and S-1 in people with Esophageal Cancer and Chemoradiation, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Esophageal Cancer, Chemoradiation
- What is being tested?
- Radiotherapy 54 Gy, Radiotherapy 60 Gy and S-1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Aug 2020
- Phase
- Phase 3
- 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histological or cytologic diagnosis of esophageal carcinoma
- ECOG performance status 0-1
- Age:70-85 years
- Joined the study voluntarily and signed informed consent form
- Patients must not have received any prior anticancer therapy
- Stage Ⅰ-ⅣB（AJCC 2009）
- Target lesions can be measured according to RECIST criteria
- No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
Who cannot join
- Multiple carcinomas of the esophagus,
- Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
- Metastatic disease (M1b),
- A primary tumor that extended to within 2 cm of the gastroesophageal junction,
- Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
- history of a second malignancy other than nonmelanoma skin cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study
This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.
- Conditions
- Esophageal Cancer, Chemoradiation
- Being tested
- Radiotherapy 54 Gy, Radiotherapy 60 Gy, S-1
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy 54 GyRadiation
Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.
Radiotherapy 60 GyRadiation
Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.
S-1Drug
S-1 70mg/m2 was administered on days 1-14 and 29-42.
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy | Experimental | Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42 Receives: Radiation: Radiotherapy 54 Gy; Drug: S-1 |
| Radiotherapy 60 Gy | Active comparator | Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly. Receives: Radiation: Radiotherapy 60 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
2-year over survival
Measured: 5 years
Secondary outcomes (2)
Progression-free survival
Measured: 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MING CHEN, PHD, Study chair, Zhejiang Cancer HospitalXIANGHUI DU, MD, Principal investigator, Zhejiang Cancer Hospitalyoungling JI, MD, Study director, Zhejiang Cancer Hospitalweiguo zhu, MD, Study director, Huai'an First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813967
- Sponsor's protocol ID
- ZJCH-E-E
- Status last verified
- Sep 2020
- First submitted
- 14 Jun 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ji Y, Fang M, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Wang X, Li P, Wang J, Xu Y, Zheng X, Chen K, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Xu W, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Kong Y, Yu X, Li H, Li R, Huang R, He H, Du X, Chen M. Long-Term Outcomes of Concurrent Chemoradiotherapy With S-1 in Older Patients With Esophageal Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263541. doi: 10.1001/jamanetworkopen.2026.3541.
PubMed 41893843Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705.
PubMed 34351356
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study
- ClinicalTrials.gov ID
- NCT02813967
- Acronym / sponsor ID
- ZJCH-E-E
- Conditions
- Esophageal Cancer, Chemoradiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 27 Jun 2016 (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.
This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy | Experimental | Radiation: Radiotherapy 54 Gy, Drug: S-1Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42 |
| Radiotherapy 60 Gy | Active comparator | Radiation: Radiotherapy 60 GyRadiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly. |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Histological or cytologic diagnosis of esophageal carcinoma
- ECOG performance status 0-1
- Age:70-85 years
- Joined the study voluntarily and signed informed consent form
- Patients must not have received any prior anticancer therapy
Key exclusion criteria (6 listed)
- Multiple carcinomas of the esophagus,
- Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
- Metastatic disease (M1b),
- A primary tumor that extended to within 2 cm of the gastroesophageal junction,
- Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
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 |
|---|---|---|
| Radiotherapy 54 GyRadiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy. | Radiation | chemoradiotherapy |
| Radiotherapy 60 GyRadiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy. | Radiation | Radiotherapy 60 Gy |
| S-1S-1 70mg/m2 was administered on days 1-14 and 29-42. | Drug | chemoradiotherapy |
Primary outcome
Overall survival
Time frame: 5 years
2-year over survival
2 secondary outcomes
Progression-free survival
Time frame: 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 5 years
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 16 Sep 2020.
- Derived from this study: PubMed 41893843Ji Y, Fang M, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Wang X, Li P, Wang J, Xu Y, Zheng X, Chen K, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Xu W, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Kong Y, Yu X, Li H, Li R, Huang R, He H, Du X, Chen M. Long-Term Outcomes of Concurrent Chemoradiotherapy With S-1 in Older Patients With Esophageal Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263541. doi: 10.1001/jamanetworkopen.2026.3541.
- Derived from this study: PubMed 34351356Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705.
- 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.
MING CHEN, PHD study chair
Zhejiang Cancer Hospital
XIANGHUI DU, MD principal investigator
Zhejiang Cancer Hospital
youngling JI, MD study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy 54 Gy, Radiotherapy 60 Gy and S-1 in people with Esophageal Cancer and Chemoradiation, run by Zhejiang Cancer Hospital at 1 site in China.
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 6 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 16 Sep 2020. 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 China. 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.
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?
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?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813967, which also lists 2 linked publications.
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 16 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.