NCT01740375

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

4.2 years

First QC Date

November 27, 2012

Last Update Submit

August 26, 2017

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 2-year disease-free survival (DFS) rate

    2 years from the enrollment of last patient

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Arm B: observation:

NO INTERVENTION

No additional treatment after concurrent chemoradiotherapy. However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.

Arm A: esophagectomy

EXPERIMENTAL

Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy

Procedure: esophagectomy

Interventions

esophagectomyPROCEDURE

esophagectomy

Arm A: esophagectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 Ă— 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Al-Batran SE, Koch C. Neoadjuvant therapy for oesophageal cancer: refining the armamentarium. Lancet. 2024 Jul 6;404(10447):5-7. doi: 10.1016/S0140-6736(24)01084-5. Epub 2024 Jun 11. No abstract available.

    PMID: 38876135DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Sung-Bae Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

KR(1)