Esophagus CancerNCT05569668
Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma
An observational study of Esophagus Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Paclitaxel- and platinum-based chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 826 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018
Who may be able to join
- Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018 and the data was prospectively collected in the hubble of the LinkDoc data company
- Surgery performed in the thoracic surgery department
- No previous cancer treatment
Who cannot join
- Patients with secondary cancer were excluded
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, 450003
About this study
Official title: Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma: A Missing Evidence and A Retrospective Case-control Study
Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. As the highest ESCC incidence area worldwid, we tried to analyze this top with big data by using a single-center case-control retrospective PMS study. Paclitaxel- and platinum-based NAC combined with two-field of the extensive mediastinal lymphadenectomy might provide better survival benefits than primary esophagectomy for stage II/III SCC.
Read the detailed description
Treatment Neoadjuvant Chemotherapy Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1.
Surgical Procedure At approximately 6-8 weeks after NAC, open (McKeown, left thoracic incision left cervical anastomosis) or MIE via thoracoscopy and/or laparoscopy was performed in the patients. Bilateral laryngeal recurrent nerve lymph node dissection was requested for every patient.
Comparisons between the NAC and primary surgery groups were performed using the chi-square test, Mann-Whitney U test and Fisher's exact test for categorical parameters after PMS. Kaplan-Meier curves and a Cox proportional hazards regression model were adopted to perform OS analysis.
- Conditions
- Esophagus Cancer
- Being tested
- Paclitaxel- and platinum-based chemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel- and platinum-based chemotherapyDrug
Neoadjuvant Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy group | Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1. Then surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. | |
| Primary surgery group | The patients would receive primary surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. . Receives: Drug: Paclitaxel- and platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS(overall survival)
OS was defined as the first date of patient admission to the inpatient thoracic surgery department to the date of death from any cause.
Measured: From date of patient admission to the inpatient thoracic surgery department until the date of first documented death from any cause, assessed up to 100 months
Secondary outcomes (1)
DFS(disease-free survival)
DFS was defined as the first day of patients admission to the inpatient department to the date of tumor recurrence confirmed by the follow-up tests.
Measured: From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Jan 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yan Zheng, PhD, MD, Principal investigator, Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569668
- Sponsor's protocol ID
- HCH2101
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- 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 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma: A Missing Evidence and A Retrospective Case-control Study
- ClinicalTrials.gov ID
- NCT05569668
- Acronym / sponsor ID
- HCH2101
- Conditions
- Esophagus Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Oct 2022 (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.
Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. As the highest ESCC incidence area worldwid, we tried to analyze this top with big data by using a single-center case-control retrospective PMS study. Paclitaxel- and platinum-based NAC combined with two-field of the extensive mediastinal lymphadenectomy might provide better survival benefits than primary esophagectomy for stage II/III SCC.
Detailed description
Treatment Neoadjuvant Chemotherapy Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1.
Surgical Procedure At approximately 6-8 weeks after NAC, open (McKeown, left thoracic incision left cervical anastomosis) or MIE via thoracoscopy and/or laparoscopy was performed in the patients. Bilateral laryngeal recurrent nerve lymph node dissection was requested for every patient.
Comparisons between the NAC and primary surgery groups were performed using the chi-square test, Mann-Whitney U test and Fisher's exact test for categorical parameters after PMS. Kaplan-Meier curves and a Cox proportional hazards regression model were adopted to perform OS analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy group | – | –Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1. Then surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. |
| Primary surgery group | – | Drug: Paclitaxel- and platinum-based chemotherapyThe patients would receive primary surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018
Key inclusion criteria (3 listed)
- Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018 and the data was prospectively collected in the hubble of the LinkDoc data company
- Surgery performed in the thoracic surgery department
- No previous cancer treatment
Key exclusion criteria (1 listed)
- Patients with secondary cancer were excluded
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 |
|---|---|---|
| Paclitaxel- and platinum-based chemotherapyNeoadjuvant Chemotherapy | Drug | Primary surgery group |
Primary outcome
OS(overall survival)
Time frame: From date of patient admission to the inpatient thoracic surgery department until the date of first documented death from any cause, assessed up to 100 months
OS was defined as the first date of patient admission to the inpatient thoracic surgery department to the date of death from any cause.
1 secondary outcome
DFS(disease-free survival)
Time frame: From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- 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.
Yan Zheng, PhD, MD principal investigator
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
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 Esophagus 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 3 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: finished, as of the sponsor's last update on 6 Oct 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OS(overall survival) (time frame: From date of patient admission to the inpatient thoracic surgery department until the date of first documented death from any cause, assessed up to 100 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 6 Oct 2022.