Esophageal Squamous Cell CarcinomaPhase 2NCT02913066
S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing S-1 concurrent radiotherapy and S-1 plus Cisplatin concurrent radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Mianyang Central Hospital at 1 site in China.
Trial summary
Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly: Experimental group: radiotherapy combined with S-1 chemotherapy. Control group: radiotherapy combined with S-1 chemotherapy and cisplatin. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- S-1 concurrent radiotherapy and S-1 plus Cisplatin concurrent radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Mar 2019
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histology or cytology confirmed esophageal squamous cell carcinoma.
- There are measurable lesions in the RECIST standard.
- American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a~ IV B period.
- Age younger than 75 years old.
- Eastern Cooperative Oncology Group physical status score was 0 ~ 1.
- No esophageal perforation and active esophageal bleeding, no obvious trachea, thoracic major vascular invasion.
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- Chest chemotherapy and radiotherapy, immunotherapy or biologic therapy have not been performed before.
- Serum hemoglobin is<100g/L, platelet>100 * 109/L,Absolute neutrophil count>1.5 * 109/L.
- Cr≤1.25 upper normal limit or CCr≥60 mL/min.
- Serum bilirubin ≤1.5 times upper normal limit, Aspartate transaminase (SGOT) and Alanine aminotransferase (SGPT) ≤ 2.5 times upper normal limit,Alkaline phosphatase≤ 5 times upper normal limit.
- A history of interstitial pneumonia and interstitial pneumonia.
- FEV1>0.8 liters.
- Patients or family members signed a formal informed consent.
Who cannot join
- Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
- Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
- Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
- Patients with distant metastases.
- There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
- Can't understand the test requirements, or patients may not comply with the requirements of the test.
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- There are other malignant lesion patients, but can cure skin cancer (non melanoma), cervical carcinoma in situ or malignant disease cured except for more than 5 years.
- An allergic reaction known to have 3 or 4 levels of any treatment.
- Had participated in other clinical trials in the past 30 days.
- The researchers believe that some of the obvious diseases that should be excluded from this study are excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaobo du
Mianyang, Sichaung, 621000
Xaiobo Du, MD, +86 08162230478, duxiaobo2005@126.com
About this study
Official title: Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy.
Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.
Read the detailed description
Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy;
control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.
Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.
Primary Outcome Measure is complete remission rate.
Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- S-1 concurrent radiotherapy, S-1 plus Cisplatin concurrent 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.
S-1 concurrent radiotherapyOther
Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle.
S-1 plus Cisplatin concurrent radiotherapyOther
Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single drug | Experimental | S-1 concurrent Radiotherapy Receives: Other: S-1 concurrent radiotherapy |
| Double drug | Active comparator | S-1 plus cisplatin concurrent Radiotherapy Receives: Other: S-1 plus Cisplatin concurrent radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate (CR)
Complete response rate of primary tumor which will be measured by endoscopy and computer tomography
Measured: Three months after radiotherapy finished
Secondary outcomes (2)
Overall Survival (OS)
The time from treatment completion to patient death
Measured: Two years after adjuvant chemotherapy finished
Progression-Free-Survival (PFS)
The time from treatment completion to disease progression
Measured: Two years after adjuvant chemotherapy finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mianyang Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Du, Mianyang Central Hospital
- Investigators
- Bo Du X, Doctor, Principal investigator, Mianyang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913066
- Sponsor's protocol ID
- XDu
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Zhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28.
PubMed 32864805
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multicenter, Phase II Noninferiority Study of S-1 Concurrent Intensity-modulated Radiation Therapy (IMRT) Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02913066
- Acronym / sponsor ID
- XDu
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Mianyang Central HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 23 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.
Will meet the inclusion criteria of patients with esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy.
Control group: radiotherapy combined with S-1 chemotherapy and cisplatin.
Detailed description
Will meet the inclusion criteria of patients with unresectable esophageal squamous cell carcinoma, divided into 2 groups randomly:
Experimental group: radiotherapy combined with S-1 chemotherapy;
control group: radiotherapy combined with S-1 chemotherapy for first to 14 days and 29 ~ 42 days, plus cisplatin first 1~ 4 days and 29 ~ 33 days. Using IMRT radiotherapy.
Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, or S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.
Primary Outcome Measure is complete remission rate.
Secondary Outcome Measures are overall survival (OS) and Progression-Free-Survival (PFS) and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single drug | Experimental | Other: S-1 concurrent radiotherapyS-1 concurrent Radiotherapy |
| Double drug | Active comparator | Other: S-1 plus Cisplatin concurrent radiotherapyS-1 plus cisplatin concurrent Radiotherapy |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Histology or cytology confirmed esophageal squamous cell carcinoma.
- There are measurable lesions in the RECIST standard.
- American Joint Committee on Cancer/Union Internationale Contre le Cancer esophageal cancer staging (Sixth Edition) clinical stage II a~ IV B period.
- Age younger than 75 years old.
- Eastern Cooperative Oncology Group physical status score was 0 ~ 1.
Key exclusion criteria (10 listed)
- Prior to the start of the trial had received thoracic radiotherapy, chemotherapy or surgical resection of esophageal cancer.
- Primary lesions were multifocal esophageal cancer patients, the lower bound of esophageal primary lesions was less than 3cm.
- Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia or a history of interstitial pneumonia.
- Patients with distant metastases.
- There were obvious esophageal ulcer, chest and back with moderate pain, and the symptoms of esophageal perforation.
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-1 concurrent radiotherapyRadiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle. | Other | Single drug |
| S-1 plus Cisplatin concurrent radiotherapyRadiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle. | Other | Double drug |
Primary outcome
Complete Remission Rate (CR)
Time frame: Three months after radiotherapy finished
Complete response rate of primary tumor which will be measured by endoscopy and computer tomography
2 secondary outcomes
Overall Survival (OS)
Time frame: Two years after adjuvant chemotherapy finished
Progression-Free-Survival (PFS)
Time frame: Two years after adjuvant chemotherapy finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Derived from this study: PubMed 32864805Zhao Z, Wen Y, Liao D, Miao J, Gui Y, Cai H, Chen Y, Wei M, Jia Q, Tian H, Sun M, Zhang Y, Feng G, Du X. Single-Agent Versus Double-Agent Chemotherapy in Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: Prospective, Randomized, Multicenter Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1900-e1908. doi: 10.1634/theoncologist.2020-0808. Epub 2020 Sep 28.
- Individual participant dataSharing planned: Yes
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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.
Bo Du X, Doctor principal investigator
Mianyang Central Hospital
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 S-1 concurrent radiotherapy and S-1 plus Cisplatin concurrent radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Mianyang Central 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 13 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 16 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Du X, Doctor (+8613550822229, duxiaobo2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission Rate (CR) (time frame: Three months after radiotherapy finished). 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 NCT02913066, 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 16 Jun 2017.