Unresectable Stage III NSCLCR-helperNCT04161352
Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC
An observational study of Unresectable Stage III NSCLC, run by Zhejiang Cancer Hospital.
Trial summary
The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Stage III NSCLC
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2019to 30 Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with untreated pathologically confirmed inoperable stage III NSCLC, suitable for the treatment of CCRT
Who may be able to join
- untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
- at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
- 18-75 years of age;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
- 10) FEV1>1.0 L;
- suitable function of bone marrow, liver, kidney and coagulation
Who cannot join
- history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Prospective Real World Study on Recombinant Human Endostatin (Endostar) Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III Non-small-cell Lung Cancer
The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.
Read the detailed description
The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.
- Conditions
- Unresectable Stage III NSCLC
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progress free survival
Measured: 15 months
Secondary outcomes (4)
OS
Overall survival
Measured: 3 years
LRFS
Locoregional relapse-free survival
Measured: 2 years
DMFS
Distant metastasis-free survival
Measured: 2 years
AEs
adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start25 Nov 2019 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Stage III NSCLCStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161352
- Sponsor's protocol ID
- Endo-CCRT-001
- Acronym
- R-helper
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only principlal investigator has the right to use all the data collected. The individual participant will not be allowed to share the data among them.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Real World Study on Recombinant Human Endostatin (Endostar) Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04161352
- Acronym / sponsor ID
- R-helper / Endo-CCRT-001
- Conditions
- Unresectable Stage III NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 25 Nov 2019 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Nov 2019 (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 chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.
Detailed description
The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with untreated pathologically confirmed inoperable stage III NSCLC, suitable for the treatment of CCRT
Key inclusion criteria (6 listed)
- untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
- at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
- 18-75 years of age;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
- 10) FEV1>1.0 L;
Key exclusion criteria (2 listed)
- history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS
Time frame: 15 months
progress free survival
4 secondary outcomes
OS
Time frame: 3 years
LRFS
Time frame: 2 years
DMFS
Time frame: 2 years
AEs
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No. Only principlal investigator has the right to use all the data collected. The individual participant will not be allowed to share the data among them.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Stage III NSCLC, run by Zhejiang Cancer Hospital.
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 6 inclusion and 2 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Chen, Doctor (18758875572, chenming@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 15 months). 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 13 Nov 2019.