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Esophageal Squamous Cell CarcinomaPhase 3ESOPRESSONCT01740375

Role of Esophagectomy in Complete Responders to CCRT

A Phase 3 study testing esophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Asan Medical Center at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
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
486 participants
Where
1 siteSouth Korea
Study dates
Nov 2012to Jan 2017
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven squamous cell carcinoma of the intrathoracic esophagus
  • Surgically resectable (cT3, cT4a and/or disease with lymph node metastasis by AJCC 7th ed) esophageal cancer, as determined by Endoscopic Ultra Sound (EUS), chest CT and PET-CT
  • No prior treatment for the esophageal cancer
  • Age: 20-70 years
  • ECOG performance status 0, 1 or 2
  • Adequate hematological, renal, hepatic, pulmonary and cardiac functions defined as 6.1 Granulocytes > 1,500/microliter, Platelets > 75,000/microliter 6.2 Creatinine < 1.5 mg/dL (or CCr> 50 mg/mL), 6.3 Total bilirubin < 1.5 mg/dL 6.4 ALT and AST < 2.5 × upper normal limit 6.5 FEV1 >=1.5 L/min 6.6 Ejection fraction >= 45%
  • Non-pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
  • Written, voluntary informed consent

Who cannot join

  • Subtypes other than squamous cell carcinoma
  • cT1N0M0, cT2N0M0 esophageal cancer or in situ carcinoma
  • Invasion of recurrent laryngeal, phrenic or sympathetic nerve
  • Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
  • Invasion of major vessels (vena cava, azygos vein and aorta) by the tumor
  • Malignant pleural effusion (documented by cytospin or cytology)
Show all 16Show fewer
  • Cervical esophageal cancer
  • Para-aortic lymph node metastasis
  • Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, curatively treated carcinoma in situ of the cervix, curatively treated early gastric cancer with endoscopic mucosal resection or a cured malignancy more than 5 years prior to enrollment
  • Previous chemotherapy or prior history of radiotherapy interfering with the planned radiotherapy as per protocol
  • Patients with a known history of HIV seropositivity or HCV (+). Patients with HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
  • Other serious illness or medical conditions A. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection (viral, bacterial or fungal infection) D. Other serious medical illnesses
  • New York heart Association Class III/IV and history of active angina. Documented myocardial infarction within the 6 months preceding registration. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks.
  • Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
  • Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  • Uncontrolled diabetes mellitus: fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control; fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control;

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus

To investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy.

Read the detailed description

After completion of concurrent chemoradiotherapy, patients will be reassed and visited to multidisciplinary clinic, then, randomized to either observation or esophagectomy.

Being tested
esophagectomy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • esophagectomyProcedure or surgery

    esophagectomy

Study groups in NCT01740375
Study groupRoleWhat they receive
Arm B: observation:No interventionNo additional treatment after concurrent chemoradiotherapy. However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
Arm A: esophagectomyExperimentalEsophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
Receives: Procedure: esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year disease-free survival (DFS) rate

    Measured: 2 years from the enrollment of last patient

Secondary outcomes (13)

  1. Overall survival (OS)

    Measured: 5 years from the enrollment of last patient

  2. progression-free survival

    Measured: 5 years from the enrollment of last patient

  3. failure pattern

    Measured: 5 years from the enrollment of last patient

  4. Number of Participants with Adverse Events

    Measured: up to 60 days after treatment

  5. Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy

    Measured: 5 years

  6. Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;

    Measured: 5 years from the enrollment of the last patient

  7. Comparison of OS according to metabolic response after induction chemotherapy

    Measured: 5 years from the enrollment of the last patient

  8. Quality of life

    Measured: 5 years from the enrollment of the last patient

  9. Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;

    Measured: 5 years from the enrollment of the last patient

  10. Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;

    Measured: 5 years from the enrollment of the last patient

  11. Comparison of PFS according to metabolic response after induction chemotherapy

    Measured: 5 years from the enrollment of the last patient

  12. Comparison of TTF according to metabolic response after induction chemotherapy

    Measured: 5 years from the enrollment of the last patient

  13. treatment-related mortality

    Measured: up to 60 days after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJan 2017
  4. Study completionJan 2017

Why it stopped: slow recruitment

Resources

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
486 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740375
Sponsor's protocol ID
Esophageal cancer AMC02
Acronym
ESOPRESSO
Status last verified
Aug 2017
First submitted
27 Nov 2012
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing esophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Asan Medical Center at 1 site in South Korea.

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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Aug 2017. 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 South Korea. 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.

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 was stopped early (reason given: slow recruitment). 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?

2-year disease-free survival (DFS) rate (time frame: 2 years from the enrollment of last patient). 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 NCT01740375.

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 Aug 2017.

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