Lung CancerNCT06019455
The Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.
An observational study of Lung Cancer and Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to assess the level of participation of thoracic cancer patients undergoing definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the association between the level of participation and patients' side effects, quality of life, and long-term survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Esophageal Cancer
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, or esophageal cancer
Who may be able to join
- Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and esophageal cancer.
- Planned to undergo definitive chemoradiotherapy ± immunotherapy;
- Males or females aged 18 to 75;
- Able to communicate with medical staff.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, 510060
Bo Qiu, Ph.D, +862087343031, qiubo@sysucc.org.cn
Hui Liu, Ph.D, +862087343031, liuhui@sysucc.org.cn
About this study
Official title: A Prospective Observational Study on the Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.
This study aims to assess the level of participation of thoracic cancer patients undergoing definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the association between the level of participation and patients' side effects, quality of life, and long-term survival. Additionally, this study will rate the level of participation from both the patients' and medical staff's perspectives and will compare the differences in ratings from these two viewpoints, as well as their impact on treatment outcomes.
- Conditions
- Lung Cancer, Esophageal Cancer
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of >=Grade 3 toxicities
The percentage of patients who develop >=Grade 3 toxicities
Measured: 2 years
Secondary outcomes (2)
Overall survival
2-year survival rate
Measured: 2 years
Progression-free survival
2-year progression-free survival rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jun 2022
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019455
- Sponsor's protocol ID
- 2023-FXY-017
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.
- ClinicalTrials.gov ID
- NCT06019455
- Acronym / sponsor ID
- 2023-FXY-017
- Conditions
- Lung Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 31 Aug 2023 (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.
This study aims to assess the level of participation of thoracic cancer patients undergoing definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the association between the level of participation and patients' side effects, quality of life, and long-term survival. Additionally, this study will rate the level of participation from both the patients' and medical staff's perspectives and will compare the differences in ratings from these two viewpoints, as well as their impact on treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | –Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, or esophageal cancer
Key inclusion criteria (4 listed)
- Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and esophageal cancer.
- Planned to undergo definitive chemoradiotherapy ± immunotherapy;
- Males or females aged 18 to 75;
- Able to communicate with medical staff.
Key exclusion criteria (0 listed)
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
Incidence of >=Grade 3 toxicities
Time frame: 2 years
The percentage of patients who develop >=Grade 3 toxicities
2 secondary outcomes
Overall survival
Time frame: 2 years
Progression-free survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Esophageal Cancer, run by Sun Yat-sen University 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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Qiu (+862087343031, qiubo@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of >=Grade 3 toxicities (time frame: 2 years). 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 10 Dec 2024.