Esophageal CancerPhase 2NCT01551641
Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
A Phase 2 study testing chemoradiotherapy, thalidomide and without thalidomide in people with Esophageal Cancer, run by Changzhou No.2 People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- chemoradiotherapy, thalidomide and without thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Mar 2016
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cytologically or histologically confirmed esophageal carcinoma
- age of 20 -80
- Karnofsky performance status ≥ 70
- no treatments prior to enrollment
- at least one measurable lesion on CT, MRI or esophageal barium exam
- normal functions of heart, lung, liver, kidney and bone marrow
- blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- informed consent signed
Who cannot join
- prior treatments of chemotherapy or irradiation
- poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- participating in other clinical trials
- pregnancy, breast feeding, or not adopting birth control
- drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no ability of self control
- coexisted morbidities that investigators believed not suitable for chemoradiation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003
Ni Cheng, M.Sc, czerykjk@yahoo.com.cn
About this study
Official title: A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.
Read the detailed description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-72Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 25 mg/m2/d, d1-4; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Administration of thalidomide: Determine serum VEGF level of the esophageal cancer patients 3-4 weeks after the beginning of radiotherapy, those whose VEGF level, compared with that before radiotherapy, increased or unchanged will be divided into two groups: one is given thalidomide concurrent with the following chemoradiotherapy, 100mg/d at bedtime for the initial week, and if no moderate above side effect occurred 200mg/d from the next week till the end of chemoradiotherapy; the other received concurrent chemoradiotherapy only.
VEGF determination: Peripheral venous blood samples will be taken in one week before, 3-4 weeks during, and in one week after radiotherapy respectively. The serum VEGF will be determined by the double antibody sandwich ELISA.
- Conditions
- Esophageal Cancer
- Being tested
- chemoradiotherapy, thalidomide, without thalidomide
- Keywords
- Esophageal Cancer, Chemoradiotherapy, VEGF, Thalidomide
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiotherapyOther
Also called chemo-radiotherapy
Patients only receive concurrent chemoradiotherapy if their serum VEGF level decrease.
thalidomideDrug
Also called neurosedyn
Patients will be given thalidomide combined with concurrent chemoradiotherapy if their serum VEGF level increase or unchanged.
without thalidomideOther
Also called without neurosedyn
Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged
| Study group | Role | What they receive |
|---|---|---|
| VEGF decressed | Experimental | patients will receive concurrent chemoradiotherapy only Receives: Other: chemoradiotherapy |
| thalidomide | Experimental | patients will be given thalidomide concurrent chemoradiotherapy Receives: Drug: thalidomide |
| without thalidomide | Experimental | patients will receive concurrent chemoradiotherapy only Receives: Other: without thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Treatment efficacy were evaluated by the indexes as Locoregional tumor response. Locoregional tumor response will be evaluated 3 months after completion of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 3 months after completion of treatment
Secondary outcomes (3)
Overall survival (OS)
Overall survival (OS) will be evaluated 1 year and 3 years after completion of treatment using Kaplan-Meier model.
Measured: 1 year and 3 years after completion of treatment
Local progression-free survival (LPFS)
1 year and 3 years after completion of treatment using Kaplan-Meier model.
Measured: 1 year and 3 years after completion of treatment
Safety
All patients are to be estimated Quality Of Life(such as dizzy, somnolence, queasiness and vomit,anaphylaxis incidence) ,acute radiation reactions such as acute radiation esophagitis and tracheitis incidence(evaluated by the Radiation Therapy Oncology Group (RTOG) toxicity criteria),complete blood cell count(such as leukocyte, neutrophil,hemoglobulin, platelet level), serum biochemistry(such as creatinine level).
Measured: 1 week after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou No.2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suping Sun, Changzhou No.2 People's Hospital
- Investigators
- Sun Suping, M.D.,PhD., Principal investigator, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551641
- Sponsor's protocol ID
- CZEY-THA-001
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01551641
- Acronym / sponsor ID
- CZEY-THA-001
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Chemoradiotherapy, VEGF, Thalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changzhou No.2 People's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 13 Mar 2012 (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 down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.
Detailed description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-72Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 25 mg/m2/d, d1-4; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Administration of thalidomide: Determine serum VEGF level of the esophageal cancer patients 3-4 weeks after the beginning of radiotherapy, those whose VEGF level, compared with that before radiotherapy, increased or unchanged will be divided into two groups: one is given thalidomide concurrent with the following chemoradiotherapy, 100mg/d at bedtime for the initial week, and if no moderate above side effect occurred 200mg/d from the next week till the end of chemoradiotherapy; the other received concurrent chemoradiotherapy only.
VEGF determination: Peripheral venous blood samples will be taken in one week before, 3-4 weeks during, and in one week after radiotherapy respectively. The serum VEGF will be determined by the double antibody sandwich ELISA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VEGF decressed | Experimental | Other: chemoradiotherapypatients will receive concurrent chemoradiotherapy only |
| thalidomide | Experimental | Drug: thalidomidepatients will be given thalidomide concurrent chemoradiotherapy |
| without thalidomide | Experimental | Other: without thalidomidepatients will receive concurrent chemoradiotherapy only |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- cytologically or histologically confirmed esophageal carcinoma
- age of 20 -80
- Karnofsky performance status ≥ 70
- no treatments prior to enrollment
- at least one measurable lesion on CT, MRI or esophageal barium exam
Key exclusion criteria (7 listed)
- prior treatments of chemotherapy or irradiation
- poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- participating in other clinical trials
- pregnancy, breast feeding, or not adopting birth control
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 |
|---|---|---|
| chemoradiotherapyAlso: chemo-radiotherapyPatients only receive concurrent chemoradiotherapy if their serum VEGF level decrease. | Other | VEGF decressed |
| thalidomideAlso: neurosedynPatients will be given thalidomide combined with concurrent chemoradiotherapy if their serum VEGF level increase or unchanged. | Drug | thalidomide |
| without thalidomideAlso: without neurosedynPatients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged | Other | without thalidomide |
Primary outcome
Treatment efficacy
Time frame: 3 months after completion of treatment
Treatment efficacy were evaluated by the indexes as Locoregional tumor response. Locoregional tumor response will be evaluated 3 months after completion of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST).
3 secondary outcomes
Overall survival (OS)
Time frame: 1 year and 3 years after completion of treatment
Local progression-free survival (LPFS)
Time frame: 1 year and 3 years after completion of treatment
Safety
Time frame: 1 week after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Sun Suping, M.D.,PhD. principal investigator
Changzhou No.2 People's 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 chemoradiotherapy, thalidomide and without thalidomide in people with Esophageal Cancer, run by Changzhou No.2 People's 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 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: status not confirmed, as of the sponsor's last update on 17 Feb 2016. 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 Sun Suping, M.D.,PhD. (+8651988136082, ssp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: 3 months after completion of treatment). 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 17 Feb 2016.