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

Asan Medical Center1 site in 1 country486 target enrollmentNovember 2012

ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Asan Medical Center
Enrollment: 486
Locations: 1
Primary Endpoint: 2-year disease-free survival (DFS) rate
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

January 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Sung-Bae Kim

Professor

Asan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

2-year disease-free survival (DFS) rate

Time Frame: 2 years from the enrollment of last patient

Secondary Outcomes

Overall survival (OS)(5 years from the enrollment of last patient)
progression-free survival(5 years from the enrollment of last patient)
failure pattern(5 years from the enrollment of last patient)
Number of Participants with Adverse Events(up to 60 days after treatment)
Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy(5 years)
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)
Comparison of OS according to metabolic response after induction chemotherapy(5 years from the enrollment of the last patient)
Quality of life(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;(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;(5 years from the enrollment of the last patient)
Comparison of PFS according to metabolic response after induction chemotherapy(5 years from the enrollment of the last patient)
Comparison of TTF according to metabolic response after induction chemotherapy(5 years from the enrollment of the last patient)
treatment-related mortality(up to 60 days after completion of treatment)