Cervical Esophageal CancerNCT05327517
Surgery or Chemoradiotherapy for Cervical Esophageal Cancer
A study testing Esophagectomy in people with Cervical Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Esophageal Cancer
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 31 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
- Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
- Aged 18-75 years;
- Without any contraindication of operation;
- Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN;
- Without other malignancies;
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- Expected R0 resection;
- ECOG PS 0-1;
- Volunteered to participate in the study, signed the informed consent form.
Who cannot join
- Without other malignancies;
- With mental diseases;
- With hemorrhagic disease;
- Inoperable patients;
- Pregnant or lactating women;
- Has a history of allergy to paclitaxel or cisplatin
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yin Li, MD, 861087788052, liyin@cicams.ac.cn
About this study
Official title: Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.
- Conditions
- Cervical Esophageal Cancer
- Being tested
- Esophagectomy
- Keywords
- Esophageal neoplasm, Chemoradiotherapy, Esophagectomy, Overall survival
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Also called Definitive chemoradiotherapy
Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy Receives: Procedure: Esophagectomy |
| Definitive chemoradiotherapy | Active comparator | Patients receive definitive chemoradiotherapy Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
5 year overall survival
Measured: 5 years after surgery or definitive Chemoradiotherapy is completed
Secondary outcomes (1)
Laryngo-esophageal dysfunction free survival
5 year laryngo-esophageal dysfunction free survival
Measured: 5 years after surgery or definitive Chemoradiotherapy is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start10 Apr 2022 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie He, MD, Study director, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeYin Li, MD, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327517
- Sponsor's protocol ID
- NCC3281
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: expected to be shared as an article paper after the trial ends
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial
- ClinicalTrials.gov ID
- NCT05327517
- Acronym / sponsor ID
- NCC3281
- Conditions
- Cervical Esophageal Cancer
- Keywords
- Esophageal neoplasm, Chemoradiotherapy, Esophagectomy, Overall survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 10 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Apr 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.
To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: EsophagectomyPatients receive esophagectomy or neoadjuvant therapy plus esophagectomy |
| Definitive chemoradiotherapy | Active comparator | Procedure: EsophagectomyPatients receive definitive chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
- Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
- Aged 18-75 years;
- Without any contraindication of operation;
- Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN;
Key exclusion criteria (6 listed)
- Without other malignancies;
- With mental diseases;
- With hemorrhagic disease;
- Inoperable patients;
- Pregnant or lactating women;
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 |
|---|---|---|
| EsophagectomyAlso: Definitive chemoradiotherapyPatients receive esophagectomy or definitive chemoradiotherapy according to patient preference | Procedure or surgery | Definitive chemoradiotherapy, Surgery |
Primary outcome
Overall Survival
Time frame: 5 years after surgery or definitive Chemoradiotherapy is completed
5 year overall survival
1 secondary outcome
Laryngo-esophageal dysfunction free survival
Time frame: 5 years after surgery or definitive Chemoradiotherapy is completed
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 14 Apr 2022.
- Individual participant dataSharing planned: Yes. expected to be shared as an article paper after the trial ends
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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.
Jie He, MD study director
Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Yin Li, MD principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy in people with Cervical Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 6 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 14 Apr 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?
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 Zhen Wang, MD (+8613600892432, wangzhen@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5 years after surgery or definitive Chemoradiotherapy is completed). 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 14 Apr 2022.