Esophageal CancerPhase 2NCT02545751
SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy and Thymalfasin in people with Esophageal Cancer and Metastatic Esophageal Cancer, run by Hangzhou Cancer Hospital at 1 site in China.
Trial summary
Patients with esophageal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study. 1. To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Cancer, Metastatic Esophageal Cancer, Stereotactic Body Radiation Therapy
- What is being tested?
- Stereotactic Body Radiation Therapy and Thymalfasin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed esophageal cancer which is persistent and metastatic or recurrent and metastatic;
- Patients must have at least 2 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;
- Age ≥18 years;
- Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
- ECOG performance status: 0-1;
- Life expectancy ≥ 3 months.
- Patients have adequate baseline organ and marrow function as defined by an absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
- Signed consent forms voluntarily;
Who cannot join
- Patients undergoing therapy with other investigational agents.
- Women who are pregnant or breastfeeding;
- Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;
- Anticipated patient survival under 3 months;
- Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus;
- Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive heart failure within the last 6 months;
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- The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
- Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
- Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
Shixiu Wu, MD contact
Tao Song, MD contact
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310000
Shixiu Wu, MD, +8657786826086, wushixiu@medmail.com.cn
About this study
Official title: A Phase II Study of Stereotactic Body Radiation Therapy and ZADAXIN's® (Thymalfasin) Induced Tumor Effects in Patients With Heavily Pretreated, Metastatic Esophageal Cancer
Patients with esophageal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.
- To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
- To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study will help find out what effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.
Read the detailed description
- To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
- To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; Eligible are patients with metastatic esphageal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least two measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week interval with SBRT, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week for a total of 8 weeks. Tumor response is evaluated by assessing clinical and CT/MRI response for all of the measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no tumor responses, the trial will be terminated. If there are one or more tumor responses in Stage One, the trial will proceed to enroll an additional 19 patients.
- Conditions
- Esophageal Cancer, Metastatic Esophageal Cancer, Stereotactic Body Radiation Therapy, Thymalfasin
- Being tested
- Stereotactic Body Radiation Therapy, Thymalfasin
- Keywords
- Esophageal cancer, Metastatic esophageal cancer, Radiotherapy, Thymalfasin, ZADAXIN's®, Stereotactic Body Radiation Therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
SBRT is given during combined therapy to one of the metastatic lesions, 25Gy in 5 fractions (5Gy per fraction) over one week, conformally to maximally spare normal tissue or organ.
ThymalfasinDrug
Also called ZADAXIN's®
Thymalfasin treatment is given twice a week with an interval of 3-4 days until progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites.
| Study group | Role | What they receive |
|---|---|---|
| SBRT and Thymalfasin arm | Experimental | SBRT is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days until tumor progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites. Receives: Radiation: Stereotactic Body Radiation Therapy; Drug: Thymalfasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with tumor responses after the initiation of treatment.
Measured: month 1- month 6
Secondary outcomes (2)
The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.
Measured: year 0- year 2
The proportion of patients alive with tumor responses from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.
Measured: year 0- year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shixiu Wu, Hangzhou Cancer Hospital
- Investigators
- Shixiu Wu, MD, Study chair, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545751
- Sponsor's protocol ID
- Hangzhou CH
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Stereotactic Body Radiation Therapy and ZADAXIN's® (Thymalfasin) Induced Tumor Effects in Patients With Heavily Pretreated, Metastatic Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02545751
- Acronym / sponsor ID
- Hangzhou CH
- Conditions
- Esophageal Cancer, Metastatic Esophageal Cancer, Stereotactic Body Radiation Therapy, Thymalfasin
- Keywords
- Esophageal cancer, Metastatic esophageal cancer, Radiotherapy, Thymalfasin, ZADAXIN's®, Stereotactic Body Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Hangzhou Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Sep 2015 (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.
Patients with esophageal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.
- To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
- To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study will help find out what effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.
Detailed description
- To observe immunity-mediated tumor response after Stereotactic Body Radiation Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
- To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; Eligible are patients with metastatic esphageal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least two measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week interval with SBRT, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week for a total of 8 weeks. Tumor response is evaluated by assessing clinical and CT/MRI response for all of the measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no tumor responses, the trial will be terminated. If there are one or more tumor responses in Stage One, the trial will proceed to enroll an additional 19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT and Thymalfasin arm | Experimental | Radiation: Stereotactic Body Radiation Therapy, Drug: ThymalfasinSBRT is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days until tumor progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically confirmed esophageal cancer which is persistent and metastatic or recurrent and metastatic;
- Patients must have at least 2 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;
- Age ≥18 years;
- Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
- ECOG performance status: 0-1;
Key exclusion criteria (9 listed)
- Patients undergoing therapy with other investigational agents.
- Women who are pregnant or breastfeeding;
- Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;
- Anticipated patient survival under 3 months;
- Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus;
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 |
|---|---|---|
| Stereotactic Body Radiation TherapyAlso: SBRTSBRT is given during combined therapy to one of the metastatic lesions, 25Gy in 5 fractions (5Gy per fraction) over one week, conformally to maximally spare normal tissue or organ. | Radiation | SBRT and Thymalfasin arm |
| ThymalfasinAlso: ZADAXIN's®Thymalfasin treatment is given twice a week with an interval of 3-4 days until progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites. | Drug | SBRT and Thymalfasin arm |
Primary outcome
The proportion of patients with tumor responses after the initiation of treatment.
Time frame: month 1- month 6
2 secondary outcomes
The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.
Time frame: year 0- year 2
The proportion of patients alive with tumor responses from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.
Time frame: year 0- year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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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.
Shixiu Wu, MD contact
Tao Song, MD contact
Shixiu Wu, MD study chair
Hangzhou 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 2 study testing Stereotactic Body Radiation Therapy and Thymalfasin in people with Esophageal Cancer and Metastatic Esophageal Cancer, run by Hangzhou 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 9 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 28 Nov 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 Shixiu Wu, MD (wushixiu@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with tumor responses after the initiation of treatment. (time frame: month 1- month 6). 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 28 Nov 2017.