Esophageal Squamous Cell CarcinomaPhase 2ESO-Shanghai9NCT02916511
Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Paclitaxel, Carboplatin and Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Paclitaxel, Carboplatin and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 1 Jul 2023
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Joined the study voluntarily and signed informed consent form;
- Age 18-75;
- ECOG 0-2;
- Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
- The operative incision healed well;
- T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
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- No radiotherapy, chemotherapy or other treatments pre (post) surgery;
- PS ECOG 0-2;
- Life expectancy of more than 3 months;
- Hemoglobin (Hb) ≥ 9 g/dL • WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L • platelet count (Pt) ≥ 100 x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN • Renal function: creatinine < 1.5 x ULN
- No immuno-deficiency;
- Use of an effective contraceptive for adults to prevent pregnancy.
Who cannot join
- Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- Participation in other interventional clinical trials within 30 days;
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- Drug addiction, Alcoholism or AIDS;
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- Unsuitable to be enrolled in the trial in the opinion of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Paclitaxel, Carboplatin, Radiotherapy
- 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.
PaclitaxelDrug
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
CarboplatinDrug
carboplatin AUC=2, ivgtt, d1, qw*5
RadiotherapyRadiation
1.8Gy/d, d1-5/week, 25Fx
| Study group | Role | What they receive |
|---|---|---|
| Chemo-radiation group | Experimental | A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks.
The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes.
Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5 Receives: Drug: Paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Measured: 2 years
Secondary outcomes (1)
overall survival
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 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2023
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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916511
- Sponsor's protocol ID
- ESO-Shanghai9
- Acronym
- ESO-Shanghai9
- Status last verified
- Dec 2023
- First submitted
- 26 Sep 2016
- Last updated
- 22 Dec 2023
- Results posted
- No
Publications
Shen J, Ai D, Chen Y, Liu Q, Deng J, Hao S, Zhang X, Zhang J, Zhang Y, Chu L, Sun Y, Zhang Y, Xiang J, Miao L, Chen H, Zhu H, Zhao K. Postoperative chemoradiotherapy for esophageal squamous cell Carcinoma: Results from ESO-Shanghai 17 and joint analyses for phase II clinical trials. Clin Transl Radiat Oncol. 2025 Nov 21;57:101073. doi: 10.1016/j.ctro.2025.101073. eCollection 2026 Mar.
PubMed 41531940Ai D, Chen Y, Liu Q, Deng J, Zhang X, Zhang J, Chu L, Shen J, Ma L, Zhang Y, Chen H, Miao L, Zhao K, Xiang J. Extensive clinical target volume in postoperative chemoradiotherapy for esophageal squamous cell carcinoma: a phase II clinical trial (ESO-Shanghai 9). Radiat Oncol. 2023 Feb 7;18(1):26. doi: 10.1186/s13014-023-02211-w.
PubMed 36750858
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02916511
- Acronym / sponsor ID
- ESO-Shanghai9 / ESO-Shanghai9
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 Sep 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.
The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo-radiation group | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Radiation: RadiotherapyA total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes. Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Joined the study voluntarily and signed informed consent form;
- Age 18-75;
- ECOG 0-2;
- Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
- The operative incision healed well;
Key exclusion criteria (7 listed)
- Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- Participation in other interventional clinical trials within 30 days;
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- Drug addiction, Alcoholism or AIDS;
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 |
|---|---|---|
| Paclitaxelpaclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5 | Drug | Chemo-radiation group |
| Carboplatincarboplatin AUC=2, ivgtt, d1, qw*5 | Drug | Chemo-radiation group |
| Radiotherapy1.8Gy/d, d1-5/week, 25Fx | Radiation | Chemo-radiation group |
Primary outcome
Local control rate
Time frame: 2 years
1 secondary outcome
overall survival
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 22 Dec 2023.
- Derived from this study: PubMed 41531940Shen J, Ai D, Chen Y, Liu Q, Deng J, Hao S, Zhang X, Zhang J, Zhang Y, Chu L, Sun Y, Zhang Y, Xiang J, Miao L, Chen H, Zhu H, Zhao K. Postoperative chemoradiotherapy for esophageal squamous cell Carcinoma: Results from ESO-Shanghai 17 and joint analyses for phase II clinical trials. Clin Transl Radiat Oncol. 2025 Nov 21;57:101073. doi: 10.1016/j.ctro.2025.101073. eCollection 2026 Mar.
- Derived from this study: PubMed 36750858Ai D, Chen Y, Liu Q, Deng J, Zhang X, Zhang J, Chu L, Shen J, Ma L, Zhang Y, Chen H, Miao L, Zhao K, Xiang J. Extensive clinical target volume in postoperative chemoradiotherapy for esophageal squamous cell carcinoma: a phase II clinical trial (ESO-Shanghai 9). Radiat Oncol. 2023 Feb 7;18(1):26. doi: 10.1186/s13014-023-02211-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Carboplatin and Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Fudan University 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 12 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: finished, as of the sponsor's last update on 22 Dec 2023. 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 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?
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?
Local control rate (time frame: 2 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 NCT02916511, 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 22 Dec 2023.