Esophageal Squamous Cell CarcinomaNCT04519905
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
A study testing Paclitaxel plus carboplatin and radiotherapy in people with Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, run by Fudan University at 3 sites in China.
Trial summary
So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus… Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Survival
- What is being tested?
- Paclitaxel plus carboplatin and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesChina
- Study dates
- 6 Jan 2020to Dec 2027
- Phase
- Interventional
- 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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Indicates no limit on eligibility based on the sex of participants
- The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
- Esophageal squamous cell carcinoma confirmed by pathology
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
- 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
- ECOG 0-1.
- Life expectancy of more than 3 months.
Who cannot join
- Total radiotherapy dose cannot reach 61.2Gy/34Fx
- 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
Show all 10Show fewer
- Pregnant or breast-feeding women or fertile patients
- Drug addiction,
- alcoholism or AIDS
- Uncontrolled seizures or psychiatric disorders
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
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, 18017312534, kuaile_z@sina.com
About this study
So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Read the detailed description
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.
Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.
- Being tested
- Paclitaxel plus carboplatin, radiotherapy
- Keywords
- esophageal squamous cell carcinoma, elderly patients, chemoradiotherapy, definitive radiotherapy, survival
- 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.
Paclitaxel plus carboplatinDrug
Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
radiotherapyRadiation
Different radiotherapy dose in different groups.
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy | Experimental | 50.4Gy/28Fx; Paclitaxel plus carboplatin Receives: Drug: Paclitaxel plus carboplatin; Radiation: radiotherapy |
| radiotherapy | Active comparator | 61.2Gy/34Fx Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival difference of definitive radiotherapy and chemoradiotherapy groups
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: 3-year
Secondary outcomes (3)
difference of quality of life between different groups
Assess the quality of life through life quality questionnaire.
Measured: the period of treatment within 7 weeks and follow up time with an average of 3months
radiation side effects
Record the radiation side effects including acute and late side effects.
Measured: acute side effects within 3 months, late side effects for 3 months later
cancer specific survival
The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start6 Jan 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, Jiangsu Cancer Institute & Hospital, Gansu Cancer Hospital, The First Affiliated Hospital of Xiamen University, Fujian Cancer Hospital, Taihe Hospital, Wuxi No. 4 People's Hospital, Ningbo No.2 Hospital
- Responsible party
- Sponsor
- Investigators
- Kuaile Zhao, doctor, Study chair, Fudan UniversityXiangpeng Zheng, doctor, Principal investigator, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519905
- Sponsor's protocol ID
- ESO-Shanghai15
- Status last verified
- Oct 2021
- First submitted
- 12 Aug 2020
- Last updated
- 2 Nov 2021
- Results posted
- 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 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
- ClinicalTrials.gov ID
- NCT04519905
- Acronym / sponsor ID
- ESO-Shanghai15
- Keywords
- esophageal squamous cell carcinoma, elderly patients, chemoradiotherapy, definitive radiotherapy, survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huadong Hospital, Jiangsu Cancer Institute & Hospital, Gansu Cancer Hospital, The First Affiliated Hospital of Xiamen University, Fujian Cancer Hospital, Taihe Hospital, Wuxi No. 4 People's Hospital, Ningbo No.2 Hospital
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Aug 2020 (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.
So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Detailed description
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.
Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy | Experimental | Drug: Paclitaxel plus carboplatin, Radiation: radiotherapy50.4Gy/28Fx; Paclitaxel plus carboplatin |
| radiotherapy | Active comparator | Radiation: radiotherapy61.2Gy/34Fx |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Indicates no limit on eligibility based on the sex of participants
- The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
- Esophageal squamous cell carcinoma confirmed by pathology
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
Key exclusion criteria (10 listed)
- Total radiotherapy dose cannot reach 61.2Gy/34Fx
- 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 |
|---|---|---|
| Paclitaxel plus carboplatinPaclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw | Drug | chemoradiotherapy |
| radiotherapyDifferent radiotherapy dose in different groups. | Radiation | chemoradiotherapy, radiotherapy |
Primary outcome
overall survival difference of definitive radiotherapy and chemoradiotherapy groups
Time frame: 3-year
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.
3 secondary outcomes
difference of quality of life between different groups
Time frame: the period of treatment within 7 weeks and follow up time with an average of 3months
radiation side effects
Time frame: acute side effects within 3 months, late side effects for 3 months later
cancer specific survival
Time frame: 3-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 2 Nov 2021.
- 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.
Kuaile Zhao, doctor study chair
Fudan University
Xiangpeng Zheng, doctor principal investigator
Huadong Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel plus carboplatin and radiotherapy in people with Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, 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 10 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: looking for participants now, as of the sponsor's last update on 2 Nov 2021. 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.
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 Kuaile Zhao, doctor (18017312534 ext. 021-64175590, kuaile_z@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival difference of definitive radiotherapy and chemoradiotherapy groups (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 2 Nov 2021.