Role of Esophagectomy in Complete Responders to CCRT

Esophageal Squamous Cell Carcinoma Clinical Trial

— ESOPRESSO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01740375
• Other study ID #: Esophageal cancer AMC02
• Status: Terminated
• Phase: Phase 3
• First received: November 27, 2012
• Last updated: August 26, 2017
• Start date: November 2012
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 486
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Procedure:
• esophagectomy
esophagectomy

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year disease-free survival (DFS) rate		2 years from the enrollment of last patient
Secondary	Overall survival (OS)		5 years from the enrollment of last patient
Secondary	progression-free survival		5 years from the enrollment of last patient
Secondary	failure pattern		5 years from the enrollment of last patient
Secondary	Number of Participants with Adverse Events		up to 60 days after treatment
Secondary	Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy		5 years
Secondary	Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;		5 years from the enrollment of the last patient
Secondary	Comparison of OS according to metabolic response after induction chemotherapy		5 years from the enrollment of the last patient
Secondary	Quality of life		5 years from the enrollment of the last patient
Secondary	Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;		5 years from the enrollment of the last patient
Secondary	Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;		5 years from the enrollment of the last patient
Secondary	Comparison of PFS according to metabolic response after induction chemotherapy		5 years from the enrollment of the last patient
Secondary	Comparison of TTF according to metabolic response after induction chemotherapy		5 years from the enrollment of the last patient
Secondary	treatment-related mortality		up to 60 days after completion of treatment