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Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740375
Recruitment Status : Terminated (slow recruitment)
First Posted : December 4, 2012
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sung-Bae Kim, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Procedure: esophagectomy Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
Study Start Date : November 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/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.
Experimental: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
Procedure: esophagectomy
esophagectomy




Primary Outcome Measures :
  1. 2-year disease-free survival (DFS) rate [ Time Frame: 2 years from the enrollment of last patient ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years from the enrollment of last patient ]
  2. progression-free survival [ Time Frame: 5 years from the enrollment of last patient ]
  3. failure pattern [ Time Frame: 5 years from the enrollment of last patient ]
  4. Number of Participants with Adverse Events [ Time Frame: up to 60 days after treatment ]
  5. Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy [ Time Frame: 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; [ Time Frame: 5 years from the enrollment of the last patient ]
  7. Comparison of OS according to metabolic response after induction chemotherapy [ Time Frame: 5 years from the enrollment of the last patient ]
  8. Quality of life [ Time Frame: 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; [ Time Frame: 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; [ Time Frame: 5 years from the enrollment of the last patient ]
  11. Comparison of PFS according to metabolic response after induction chemotherapy [ Time Frame: 5 years from the enrollment of the last patient ]
  12. Comparison of TTF according to metabolic response after induction chemotherapy [ Time Frame: 5 years from the enrollment of the last patient ]
  13. treatment-related mortality [ Time Frame: up to 60 days after completion of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven squamous cell carcinoma of the intrathoracic esophagus
  2. 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
  3. No prior treatment for the esophageal cancer
  4. Age: 20-70 years
  5. ECOG performance status 0, 1 or 2
  6. 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%
  7. Non-pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
  8. Written, voluntary informed consent

Exclusion Criteria:

  1. Subtypes other than squamous cell carcinoma
  2. cT1N0M0, cT2N0M0 esophageal cancer or in situ carcinoma
  3. Invasion of recurrent laryngeal, phrenic or sympathetic nerve
  4. Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
  5. Invasion of major vessels (vena cava, azygos vein and aorta) by the tumor
  6. Malignant pleural effusion (documented by cytospin or cytology)
  7. Cervical esophageal cancer
  8. Para-aortic lymph node metastasis
  9. 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
  10. Previous chemotherapy or prior history of radiotherapy interfering with the planned radiotherapy as per protocol
  11. 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.
  12. 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
  13. 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.
  14. Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
  15. Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  16. 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740375


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sung-Bae Kim, MD, PhD Asan Medical Center
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Responsible Party: Sung-Bae Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01740375    
Other Study ID Numbers: Esophageal cancer AMC02
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases