Esophageal CancerNCT06061263
Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve PCR to Neoadjuvant Chemoradiotherapy
An observational study of Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
It has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (PCR) to neoadjuvant chemoradiotherapy have better survival than those with non-PCR. Howeve, there is still recurrent diseases developed in PCR patients after esophagectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- follow up
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all the ESCC patients with PCR to nCRT betwee 2008 and 2018 who received cisplabin plus or cisplain plus as the preoperative chemotherapy regimen.
Who may be able to join
- patients with histopathologically confirmed ESCC;(2) patients received nCRT and radical esophagectomy in our hospital;(3) patients received the cisplabin plus or cisplain plus as the preoperative chemotherapy regimen; (4) those patients achieved PCR in the postoperative specimens (both primary tumor and resected lymph nodes).
Who cannot join
- patients who did not receive preoperative treatment or received preoperative chemotherapy alone;(2) patients who underwent Ivor-Lewis esophagectomy or Sweet esophagectomy;(3) patients who received preoperative chemotherapy other than NP or DP regimens;(4) patients with non-PCR to nCRT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Patterns and Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve Pathologic Complete Response to Neoadjuvant Chemoradiotherapy
It has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (PCR) to neoadjuvant chemoradiotherapy have better survival than those with non-PCR. Howeve, there is still recurrent diseases developed in PCR patients after esophagectomy. Herein, we aimed to investgate the risk factors of recurrence in PCR patients.
Read the detailed description
Between January 2008 and December 2018, a total of 96 patients with pathological complete response were enrolled in this study. Sterilized lymph nodes (SLN) were defined as those lymph nodes without residual tumor but with the presence of treatment response to neoadjuvant chemoradiotherapy. Prognostic factors for recurrence-free survival (RFS) were analyzed with univariate and multivariate analyses.
- Conditions
- Esophageal Cancer
- Being tested
- follow up
- Keywords
- risk factor
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow upOther
collecttion of clinicopathological data from a prespectively collected databse, including survival data.
| Study group | Role | What they receive |
|---|---|---|
| PCR patients with eaophageal squamous cell carcinomas | patients with esophageal squamous cell carcinoma (ESCC) patients who achieved pathologic complete response after neoadjuvant chemoradiotherapy (nCRT). Receives: Other: follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival
recurrence-free survival (RFS) was calculated from the date of esophagectomy to the date of first detected recurrent disease
Measured: 2008-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 May 2022
- Primary completion30 Jun 2023
- Study completionDec 2023 (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.
- 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
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua Fu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061263
- Sponsor's protocol ID
- 202212901
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patterns and Risk Factors of Relapse in Esophageal Squamous Cell Cancers Who Achieve Pathologic Complete Response to Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT06061263
- Acronym / sponsor ID
- 202212901
- Conditions
- Esophageal Cancer
- Keywords
- risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Sep 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.
It has been reported that patients with esophageal squamous cell carcinoma who achieved pathological complete response (PCR) to neoadjuvant chemoradiotherapy have better survival than those with non-PCR. Howeve, there is still recurrent diseases developed in PCR patients after esophagectomy. Herein, we aimed to investgate the risk factors of recurrence in PCR patients.
Detailed description
Between January 2008 and December 2018, a total of 96 patients with pathological complete response were enrolled in this study. Sterilized lymph nodes (SLN) were defined as those lymph nodes without residual tumor but with the presence of treatment response to neoadjuvant chemoradiotherapy. Prognostic factors for recurrence-free survival (RFS) were analyzed with univariate and multivariate analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCR patients with eaophageal squamous cell carcinomas | – | Other: follow uppatients with esophageal squamous cell carcinoma (ESCC) patients who achieved pathologic complete response after neoadjuvant chemoradiotherapy (nCRT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all the ESCC patients with PCR to nCRT betwee 2008 and 2018 who received cisplabin plus or cisplain plus as the preoperative chemotherapy regimen.
Key inclusion criteria (1 listed)
- patients with histopathologically confirmed ESCC;(2) patients received nCRT and radical esophagectomy in our hospital;(3) patients received the cisplabin plus or cisplain plus as the preoperative chemotherapy regimen; (4) those patients achieved PCR in the postoperative specimens (both primary tumor and resected lymph nodes).
Key exclusion criteria (1 listed)
- patients who did not receive preoperative treatment or received preoperative chemotherapy alone;(2) patients who underwent Ivor-Lewis esophagectomy or Sweet esophagectomy;(3) patients who received preoperative chemotherapy other than NP or DP regimens;(4) patients with non-PCR to nCRT.
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 |
|---|---|---|
| follow upcollecttion of clinicopathological data from a prespectively collected databse, including survival data. | Other | PCR patients with eaophageal squamous cell carcinomas |
Primary outcome
recurrence-free survival
Time frame: 2008-2018
recurrence-free survival (RFS) was calculated from the date of esophagectomy to the date of first detected recurrent disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of 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 1 inclusion and 1 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 29 Sep 2023. 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?
Results are not available in the source record.
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?
recurrence-free survival (time frame: 2008-2018). 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 29 Sep 2023.