Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)
A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Arm B: observation:
No additional treatment after concurrent chemoradiotherapy.
However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
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|
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Experimental: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
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esophagectomy
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
2-year disease-free survival (DFS) rate
Time Frame: 2 years from the enrollment of last patient
|
2 years from the enrollment of last patient
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival (OS)
Time Frame: 5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
progression-free survival
Time Frame: 5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
failure pattern
Time Frame: 5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
Number of Participants with Adverse Events
Time Frame: up to 60 days after treatment
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up to 60 days after treatment
|
|
Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy
Time Frame: 5 years
|
5 years
|
|
Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Time Frame: 5 years from the enrollment of the last patient
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5 years from the enrollment of the last patient
|
|
Comparison of OS according to metabolic response after induction chemotherapy
Time Frame: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Quality of life
Time Frame: 5 years from the enrollment of the last patient
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5 years from the enrollment of the last patient
|
|
Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Time Frame: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Time Frame: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of PFS according to metabolic response after induction chemotherapy
Time Frame: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of TTF according to metabolic response after induction chemotherapy
Time Frame: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
treatment-related mortality
Time Frame: up to 60 days after completion of treatment
|
up to 60 days after completion of treatment
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
Other Study ID Numbers
- Esophageal cancer AMC02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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