Esophageal CancerNCT03110939
Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
A study testing hyperthermic perfusion in people with Esophageal Cancer and Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Lung Cancer, Hyperthermic Perfusion
- What is being tested?
- hyperthermic perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2017to 5 Apr 2021
- Phase
- Interventional
- 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
- Patients must not have received any prior anticancer therapy of cancer.
- expected R0 resection.
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of T3-4, any N and any T, N1. (8th Union for International Cancer Control, Union for International Cancer Control(UICC)-TNM). Histologic diagnosis of non small cell lung cancer, T2-T3, any N. (8th Union for International Cancer Control, UICC-TNM)
- Age ranges from 18 to 80 years.
- Without operative contraindication.
- Eastern Cooperative Oncology Group (ECOG) 0～2.
- Signed informed consent document on file.
Who cannot join
- Multiple primary cancer.
- The subject cannot understand and sign the informed consent form(ICF).
- Patients with concomitant hemorrhagic disease.
- Any un expected reason for patients can't get operation.
- Pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, 450008
About this study
Official title: A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.
- Conditions
- Esophageal Cancer, Lung Cancer, Hyperthermic Perfusion
- Being tested
- hyperthermic perfusion
- Medical subject headings
- Esophageal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermic perfusionOther
hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after surgery of advanced lung cancer/esophageal cancer)
| Study group | Role | What they receive |
|---|---|---|
| hyperthermic perfusion group | Experimental | hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after standard surgery of advanced lung cancer/esophageal cancer) Receives: Other: hyperthermic perfusion |
| control group | No intervention | standard surgery of advanced lung cancer/esophageal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrent rate
recurrent within thoracic cavity
Measured: 3 years after surgery
Secondary outcomes (5)
Total complication rate
The total complications mean anastomotic fistula, hydrothorax, pneumonia, pleural hemorrhage and cardiac together.
Measured: 6 months after surgery
The Clavien-Dindo classification
the classification surgical complications after surgery/intrathoracic hyperthermic perfusion
Measured: 6 months after surgery
mortality rate during operation/intrathoracic hyperthermic perfusion
mortality rate during operation/intrathoracic hyperthermic perfusion
Measured: during operation/intrathoracic hyperthermic perfusion
vital signs during treatment
The heart rate, blood pressure and body temperature will be recorded every 10 mins during intrathoracic hyperthermic perfusion
Measured: during operation/intrathoracic hyperthermic perfusion
mortality rate after treatment
mortality rate after treatment
Measured: 2 months after surgery/intrathoracic hyperthermic perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start21 Mar 2017
- Primary completion5 Apr 2019 (estimated)
- Study completion5 Apr 2021 (estimated)
Why it stopped: The principal investigator Dr.YinLi is working in other Hospital
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.
- More trials run by Henan Cancer HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yin Li, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110939
- Sponsor's protocol ID
- HenanCH2016ct082
- Status last verified
- Jan 2020
- First submitted
- 28 Mar 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03110939
- Acronym / sponsor ID
- HenanCH2016ct082
- Conditions
- Esophageal Cancer, Lung Cancer, Hyperthermic Perfusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The principal investigator Dr.YinLi is working in other Hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 5 Apr 2019 (estimated)
- Study completion
- 5 Apr 2021 (estimated)
- First posted
- 12 Apr 2017 (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.
The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperthermic perfusion group | Experimental | Other: hyperthermic perfusionhyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after standard surgery of advanced lung cancer/esophageal cancer) |
| control group | No intervention | –standard surgery of advanced lung cancer/esophageal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must not have received any prior anticancer therapy of cancer.
- expected R0 resection.
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of T3-4, any N and any T, N1. (8th Union for International Cancer Control, Union for International Cancer Control(UICC)-TNM). Histologic diagnosis of non small cell lung cancer, T2-T3, any N. (8th Union for International Cancer Control, UICC-TNM)
- Age ranges from 18 to 80 years.
- Without operative contraindication.
Key exclusion criteria (5 listed)
- Multiple primary cancer.
- The subject cannot understand and sign the informed consent form(ICF).
- Patients with concomitant hemorrhagic disease.
- Any un expected reason for patients can't get operation.
- Pregnant or breast feeding.
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 |
|---|---|---|
| hyperthermic perfusionhyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after surgery of advanced lung cancer/esophageal cancer) | Other | hyperthermic perfusion group |
Primary outcome
local recurrent rate
Time frame: 3 years after surgery
recurrent within thoracic cavity
5 secondary outcomes
Total complication rate
Time frame: 6 months after surgery
The Clavien-Dindo classification
Time frame: 6 months after surgery
mortality rate during operation/intrathoracic hyperthermic perfusion
Time frame: during operation/intrathoracic hyperthermic perfusion
vital signs during treatment
Time frame: during operation/intrathoracic hyperthermic perfusion
mortality rate after treatment
Time frame: 2 months after surgery/intrathoracic hyperthermic perfusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperthermic perfusion in people with Esophageal Cancer and Lung Cancer, run by Henan 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 5 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: withdrawn, as of the sponsor's last update on 22 Jan 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrent rate (time frame: 3 years after surgery). 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 22 Jan 2020.