Radiotherapy Side EffectNCT04027543
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
An observational study of Radiotherapy Side Effect and Chemotherapy Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in 2 countries.
Trial summary
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiotherapy Side Effect, Chemotherapy Effect, Oesophageal Carcinoma
- What is being tested?
- Neoadjuvant chemoradiotherapy, Oesophagectomy and Neoadjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 423 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Nov 2018to 1 Dec 2019
- 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: Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction that was clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography were eligible.
Who may be able to join
- Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.
- Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography.
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Who cannot join
- Patients had received any previous treatment for oesophageal cancer.
- Patients who were unsuitable for surgery because of comorbidities.
- Patients had evidence of distant metastatic disease by history and physical examination.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
United States1 site
Massachusetts General Hospital of Harvard Medical School
Boston, Massachusetts, 01748
About this study
Official title: Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
Read the detailed description
Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.
- Conditions
- Radiotherapy Side Effect, Chemotherapy Effect, Oesophageal Carcinoma, Effect of Drugs, Safety Issues
- Being tested
- Neoadjuvant chemoradiotherapy, Oesophagectomy, Neoadjuvant chemotherapy
- Keywords
- Neoadjuvant chemoradiotherapy, Neoadjuvant chemotherapy, Resectable oesophageal carcinoma, Effective, Safety
- Medical subject headings
- Radiation Injuries, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoradiotherapyCombination product
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
OesophagectomyProcedure or surgery
Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.
Neoadjuvant chemotherapyDrug
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiotherapy | Patients who had chemoradiotherapy before surgery. Receives: Combination Product: Neoadjuvant chemoradiotherapy | |
| Neoadjuvant chemotherapy | Patients who had chemotherapy before surgery. Receives: Drug: Neoadjuvant chemotherapy | |
| Surgery alone | Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth. Receives: Procedure: Oesophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.
Measured: 5 years
Secondary outcomes (4)
Disease-free survival (DFS)
DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause
Measured: 5 years
R0 resection rate
R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).
Measured: Baseline
Pathologic complete response (pCR)
pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.
Measured: Baseline
30-day postoperative or in-hospital mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start14 Nov 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of 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
- 423 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Herui Yao, PhD, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityHaiyu Zhou, PhD, Principal investigator, Guangdong Provincial People's HospitalMichael Lanuti, PhD, Principal investigator, Massachusetts General Hospital of Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027543
- Sponsor's protocol ID
- SYSEC-KY-KS-2019-068
- Status last verified
- May 2020
- First submitted
- 18 Jul 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Zhou HY, Zheng SP, Li AL, Gao QL, Ou QY, Chen YJ, Wu ST, Lin DG, Liu SB, Huang LY, Li FS, Zhu HY, Qiao GB, Lanuti M, Yao HR, Yu YF. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study). EClinicalMedicine. 2020 Jun 27;24:100422. doi: 10.1016/j.eclinm.2020.100422. eCollection 2020 Jul.
PubMed 32637899
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)
- ClinicalTrials.gov ID
- NCT04027543
- Acronym / sponsor ID
- SYSEC-KY-KS-2019-068
- Conditions
- Radiotherapy Side Effect, Chemotherapy Effect, Oesophageal Carcinoma, Effect of Drugs, Safety Issues
- Keywords
- Neoadjuvant chemoradiotherapy, Neoadjuvant chemotherapy, Resectable oesophageal carcinoma, Effective, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Massachusetts General Hospital
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 22 Jul 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.
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
Detailed description
Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiotherapy | – | Combination Product: Neoadjuvant chemoradiotherapyPatients who had chemoradiotherapy before surgery. |
| Neoadjuvant chemotherapy | – | Drug: Neoadjuvant chemotherapyPatients who had chemotherapy before surgery. |
| Surgery alone | – | Procedure: OesophagectomyPatients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction that was clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography were eligible.
Key inclusion criteria (3 listed)
- Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.
- Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography.
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Key exclusion criteria (3 listed)
- Patients had received any previous treatment for oesophageal cancer.
- Patients who were unsuitable for surgery because of comorbidities.
- Patients had evidence of distant metastatic disease by history and physical examination.
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 |
|---|---|---|
| Neoadjuvant chemoradiotherapyIn most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes. | Combination product | Neoadjuvant chemoradiotherapy |
| OesophagectomyVarious surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth. | Procedure or surgery | Surgery alone |
| Neoadjuvant chemotherapyIn most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes. | Drug | Neoadjuvant chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: 5 years
The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.
4 secondary outcomes
Disease-free survival (DFS)
Time frame: 5 years
R0 resection rate
Time frame: Baseline
Pathologic complete response (pCR)
Time frame: Baseline
30-day postoperative or in-hospital mortality
Time frame: 30 days
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 29 May 2020.
- Derived from this study: PubMed 32637899Zhou HY, Zheng SP, Li AL, Gao QL, Ou QY, Chen YJ, Wu ST, Lin DG, Liu SB, Huang LY, Li FS, Zhu HY, Qiao GB, Lanuti M, Yao HR, Yu YF. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study). EClinicalMedicine. 2020 Jun 27;24:100422. doi: 10.1016/j.eclinm.2020.100422. eCollection 2020 Jul.
- Individual participant dataSharing planned: No. The datasets used or analysed during the current study are available from the corresponding author on reasonable request.
Related trials for Radiotherapy Side Effect
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
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.
Herui Yao, PhD study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Haiyu Zhou, PhD principal investigator
Guangdong Provincial People's Hospital
Michael Lanuti, PhD principal investigator
Massachusetts General Hospital of Harvard Medical School
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect and Chemotherapy Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in 2 countries.
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 3 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 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, United States. 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?
Overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027543, which also lists 1 linked publication.
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 May 2020.