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


Phase 3
20 Years
70 Years
Open (Enrolling)
Both
Esophageal Squamous Cell Carcinoma

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Trial Information

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


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;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year disease-free survival (DFS) rate

Outcome Time Frame:

2 years from the enrollement of last patient

Safety Issue:

No

Authority:

Korea: Institutional Review Board

Study ID:

Esophageal cancer AMC02

NCT ID:

NCT01740375

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases

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