Esophageal Squamous Cell CarcinomaPhase 3NCT03790553
Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
A Phase 3 study testing Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 3 sites in China.
Trial summary
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced 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?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 3 sitesChina
- Study dates
- 15 Oct 2018to 15 Oct 2025
- 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 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 years; both genders
- Esophageal squamous cell carcinoma confirmed by pathology.
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
- Use of an effective contraceptive for adults to prevent pregnancy.
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- No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
- WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥ 100*109/L, ALAT and ASAT < 2·5 * ULN, TBIL < 1·5 * ULN, and Creatinine < 1·5 *ULN.
- ECOG 0-2.
- Life expectancy of more than 3 months.
- Agreement of PET/CT accessment at 25-28 radiotherapy fraction.
Who cannot join
- Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
- Esophageal perforation, or hematemesis.
- History of radiotherapy or chemotherapy for esophageal cancer.
- History of surgery within 28 days before Day 1.
- History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years).
- Participation in other interventional clinical trials within 30 days.
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- Pregnant or breast-feeding women or fertile patients who refused to use contraceptives.
- Drug addiction, alcoholism or AIDS.
- Uncontrolled seizures or psychiatric disorders.
- Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Jinjun C Ye, M.D., 13585175433 ext. 13585175433, jjye2004@163.com
Jinjun C Ye, M.D.
- Recruiting
Huadong Hospital
Shanghai, Shanghai Municipality, 200000
Xiangpeng Zheng, M.D., 8621-62483180 ext. 862162483180, zhengxp@fudan.edu.cn
Xiangpeng Zheng, 862162483180 ext. 862162483180, zhengxp@fudan.edu.cn
- Recruiting
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Kuaile Zhao, MD., +8618017312534, kuaile_z@sina.com
About this study
Official title: A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Radiotherapy
- Keywords
- chemoradiotherapy, esophageal cancer, PET/CT
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Different total radiotherapy dose between two arms.
| Study group | Role | What they receive |
|---|---|---|
| 50.4Gy | Active comparator | Total radiotherapy dose of 50.4Gy. Receives: Radiation: Radiotherapy |
| 61.2Gy | Experimental | Total radiotherapy dose of 61.2Gy. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in PET/CT non-responders
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Measured: 2 years
Overall survival in ITT population
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Measured: 2 years
Secondary outcomes (5)
Local control rate
The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)
Measured: 2 years
Progression-free survival
(defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)
Measured: 2 years
Overall survival in PET/CT responders
Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.
Measured: 2 years
Questionnaire EORTC-QLQ-C30
A quality of life score is obtained according to the answers to the questionnaires.
Measured: 2 years
Questionnaire EORTC-QLQ-OES18
A quality of life score is obtained according to the answers to the questionnaires.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start15 Oct 2018
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 646 participants (estimated)
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
- NCT03790553
- Sponsor's protocol ID
- ESO-Shanghai 12
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2018
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu H, Liu Q, Xu H, Mo M, Wang Z, Lu K, Zhou J, Chen J, Zheng X, Ye J, Ge X, Luo H, Liu Q, Deng J, Ai D, Hao S, Zhang J, Tseng IH, Song S, Chen Y, Zhao K. Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12). Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y.
PubMed 35906623
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT03790553
- Acronym / sponsor ID
- ESO-Shanghai 12
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- chemoradiotherapy, esophageal cancer, PET/CT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 646 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 31 Dec 2018 (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.
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50.4Gy | Active comparator | Radiation: RadiotherapyTotal radiotherapy dose of 50.4Gy. |
| 61.2Gy | Experimental | Radiation: RadiotherapyTotal radiotherapy dose of 61.2Gy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Joined the study voluntarily and signed informed consent form;
- Age 18-75 years; both genders
- Esophageal squamous cell carcinoma confirmed by pathology.
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
Key exclusion criteria (10 listed)
- Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
- Esophageal perforation, or hematemesis.
- History of radiotherapy or chemotherapy for esophageal cancer.
- History of surgery within 28 days before Day 1.
- History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years).
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 |
|---|---|---|
| RadiotherapyDifferent total radiotherapy dose between two arms. | Radiation | 50.4Gy, 61.2Gy |
Primary outcome
Overall survival in PET/CT non-responders
Time frame: 2 years
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Overall survival in ITT population
Time frame: 2 years
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
5 secondary outcomes
Local control rate
Time frame: 2 years
Progression-free survival
Time frame: 2 years
Overall survival in PET/CT responders
Time frame: 2 years
Questionnaire EORTC-QLQ-C30
Time frame: 2 years
Questionnaire EORTC-QLQ-OES18
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 35906623Zhu H, Liu Q, Xu H, Mo M, Wang Z, Lu K, Zhou J, Chen J, Zheng X, Ye J, Ge X, Luo H, Liu Q, Deng J, Ai D, Hao S, Zhang J, Tseng IH, Song S, Chen Y, Zhao K. Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12). Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y.
- Individual participant dataSharing planned: Undecided
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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.
3 sites 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 in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 3 sites 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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival in PET/CT non-responders (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03790553, which also lists 1 linked publication.
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 3 Aug 2023.