Esophageal CancersPhase 3NCT01032967
Surgery or Chemoradiation for Esophageal Cancer
A Phase 3 study testing Esophagectomy and Definitive chemoradiation in people with Esophageal Cancers, run by Chinese University of Hong Kong.
Trial summary
The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancers
- What is being tested?
- Esophagectomy and Definitive chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Jun 2009
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.
Who cannot join
- The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
- Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.
About this study
Official title: Multicenter Prospective Randomized Trial Comparing Standard Esophagectomy With Chemoradiotherapy for Treatment of Squamous Esophageal Cancer: Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)
The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).
- Conditions
- Esophageal Cancers
- Being tested
- Esophagectomy, Definitive chemoradiation
- Keywords
- squamous cell carcinoma, esophagectomy, chemoradiotherapy, chemoradiation, Squamous cell carcinomas of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
The patients will receive standard open esophagectomy with two-field lymphadenectomy
Definitive chemoradiationRadiation
3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Surgery, esophagectomy | Active comparator | The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy Receives: Procedure: Esophagectomy |
| Definitive chemoradiation | Active comparator | 3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks. Receives: Radiation: Definitive chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival and disease-free survival
Measured: 2 year and 5 year
Secondary outcomes (1)
Quality of life and function outcomes
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJul 2000
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancersStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Philip W Chiu, FRCSEd (Gen), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032967
- Sponsor's protocol ID
- Surgery or CRT Ca Esophagus
- Status last verified
- Dec 2009
- First submitted
- 15 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.
PubMed 22887465Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.
PubMed 21233603
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Trial Comparing Standard Esophagectomy With Chemoradiotherapy for Treatment of Squamous Esophageal Cancer: Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)
- ClinicalTrials.gov ID
- NCT01032967
- Acronym / sponsor ID
- Surgery or CRT Ca Esophagus
- Conditions
- Esophageal Cancers
- Keywords
- squamous cell carcinoma, esophagectomy, chemoradiotherapy, chemoradiation, Squamous cell carcinomas of the esophagus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Dec 2009 (estimated)
- 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.
The aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (CRT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery, esophagectomy | Active comparator | Procedure: EsophagectomyThe patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy |
| Definitive chemoradiation | Active comparator | Radiation: Definitive chemoradiation3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable.
Key exclusion criteria (2 listed)
- The investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve.
- Those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also 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 |
|---|---|---|
| EsophagectomyThe patients will receive standard open esophagectomy with two-field lymphadenectomy | Procedure or surgery | Surgery, esophagectomy |
| Definitive chemoradiation3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks. | Radiation | Definitive chemoradiation |
Primary outcome
Overall survival and disease-free survival
Time frame: 2 year and 5 year
1 secondary outcome
Quality of life and function outcomes
Time frame: 2 year
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 16 Dec 2009.
- Derived from this study: PubMed 22887465Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.
- Derived from this study: PubMed 21233603Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.
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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.
Philip W Chiu, FRCSEd (Gen) principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esophagectomy and Definitive chemoradiation in people with Esophageal Cancers, run by Chinese University of Hong Kong.
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 2 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 16 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 and disease-free survival (time frame: 2 year and 5 year). 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 NCT01032967, which also lists 2 linked publications.
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 16 Dec 2009.