Esophageal CancerPhase 2NCT02745561
Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
A Phase 2 study testing Endostatins, Oxaliplatin and Radiotherapy in people with Esophageal Cancer and Endostatin, run by Hangzhou Cancer Hospital at 1 site in China.
Trial summary
Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Endostatin
- What is being tested?
- Endostatins, Oxaliplatin and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically or histologically confirmed esophageal carcinoma
- Age of 18 -80
- ECOG performance status: 0-1;
- 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;
- 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
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310000
Shixiu Wu, MD, +8657186826086, wushixiu@medmail.com.cn
Tao Song, Dr, songtaodhp@126.com
About this study
Official title: A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.
- Conditions
- Esophageal Cancer, Endostatin
- Being tested
- Endostatins, Oxaliplatin, Radiotherapy
- Keywords
- Endostatin, Oxaliplatin, Esophageal Cancer, chemoradiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostatinsDrug
Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy.
OxaliplatinDrug
Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.
RadiotherapyRadiation
Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy Arm | Experimental | Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy. Receives: Drug: Endostatins; Drug: Oxaliplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Response rate will be done after 3-4 weeks following the last radiotherapy session.
Measured: week 3-4
Secondary outcomes (3)
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Measured: year 0 - year 3
Progression-free survival
Progression-free survival (PFS) will be calculated from the date of chemoradiotherapy initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.
Measured: year 0 - year 3
Overall survival
Overall survival (OS) will be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Measured: year 0 - year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 22 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745561
- Sponsor's protocol ID
- HangzhouCH05
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Li W, Chen P, Zhang N, Song T, Wu S. Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study. Oncologist. 2019 Apr;24(4):461-e136. doi: 10.1634/theoncologist.2019-0119. Epub 2019 Mar 8.
PubMed 30850562
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
- ClinicalTrials.gov ID
- NCT02745561
- Acronym / sponsor ID
- HangzhouCH05
- Conditions
- Esophageal Cancer, Endostatin
- Keywords
- Endostatin, Oxaliplatin, Esophageal Cancer, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 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
- 20 Apr 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.
Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy Arm | Experimental | Drug: Endostatins, Drug: Oxaliplatin, Radiation: RadiotherapyRadiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cytologically or histologically confirmed esophageal carcinoma
- Age of 18 -80
- ECOG performance status: 0-1;
- 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 |
|---|---|---|
| EndostatinsEndostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. | Drug | Chemoradiotherapy Arm |
| OxaliplatinOxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy. | Drug | Chemoradiotherapy Arm |
| RadiotherapyRadiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. | Radiation | Chemoradiotherapy Arm |
Primary outcome
response rate
Time frame: week 3-4
Response rate will be done after 3-4 weeks following the last radiotherapy session.
3 secondary outcomes
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Time frame: year 0 - year 3
Progression-free survival
Time frame: year 0 - year 3
Overall survival
Time frame: year 0 - year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Derived from this study: PubMed 30850562Li W, Chen P, Zhang N, Song T, Wu S. Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study. Oncologist. 2019 Apr;24(4):461-e136. doi: 10.1634/theoncologist.2019-0119. Epub 2019 Mar 8.
- 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.
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 Endostatins, Oxaliplatin and Radiotherapy in people with Esophageal Cancer and Endostatin, 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 7 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 20 Apr 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 Shixiu Wu, MD (+8657186826086, wushixiu@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: week 3-4). 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 NCT02745561, 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 20 Apr 2016.