A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC

NCT04328948 | Recruiting Phase 3

• 1 other identifier: JCOG1904
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma; chemoradiotherapy; Radiation Field

Outcome Measures

Primary Outcomes (1)

• Major progression-free survival

  If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events.

  The primary analysis will be held 5-years after the last patient was enrolled.

Secondary Outcomes (6)

• Overall survival

  The primary analysis will be held 5-years after the last patient was enrolled.

• Progression-free survival

  The primary analysis will be held 5-years after the last patient was enrolled.

• Complete response rate

  The primary analysis will be held 5-years after the last patient was enrolled.

• Esophagectomy-free survival

  The primary analysis will be held 5-years after the last patient was enrolled.

• Adverse events

  The primary analysis will be held 5-years after the last patient was enrolled.

Study Arms (2)

Chemoradiation therapy with elective nodal irradiation

EXPERIMENTAL

Chemoradiotherapy consists of 5-FU (1,000 mg / m2, day1-4, day29-32), CDDP (75 mg /m2, day1, 29) and radiotherapy (50.4 Gy/28Fr)

Radiation: Chemoradiotherapy

Chemoradiation therapy with involved field irradiation

ACTIVE COMPARATOR

Chemoradiotherapy consists of 5-FU (700 mg /m2, day1-4, day29-32), CDDP (70 mg /m2, day1,29) and radiotherapy (60 Gy/30Fr)

Radiation: Chemoradiotherapy

Interventions

Chemoradiotherapy RADIATION

Chemoradiotherapy

Chemoradiation therapy with elective nodal irradiation; Chemoradiation therapy with involved field irradiation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
• All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
• Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
• The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.
• Aged 20 years and older.
• ECOG Performance status 0 or 1.
• No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM (pM2) / pT1a-MM (M3) disease or pT1a-MM (M3) disease without vascular infiltration.
• No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.
• Major organ function is preserved. 1) WBC\<=12,000/mm3 2) ANC\>=1,500/mm3 3) Hb\>=10.0 g /dL 4) PLT\>=10,000/mm3 5) T-bil\<=1.5 mg /dL 6) AST\<=100 IU/L 7) ALT\<=100 IU/L 8) SpO2\>=95% 9) Ccr\>=60 mL/min
• Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
• Written informed consent is obtained.

You may not qualify if:

• Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.
• Active infection requiring systemic therapy.
• Fever over 38 degrees Celsius
• Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.
• Psychological disorder, which is difficult to participate in this clinical study.
• Receiving continuous systemic corticosteroid or immunosuppressant treatment.
• Positive for HBs antigen or HIV antigen.
• Diabetes mellitus, which is uncontrollable with continuous use of insulin or hypoglycemic agents.
• Uncontrolled arterial hypertension.
• History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
• Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
• Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
• With a history of cerebrovascular disorder within 6 months.
• Drug allergy for iodic drugs.

Sponsors & Collaborators

• National Cancer Center, Japan: lead

Study Sites (1)

National Cancer Center Hospital

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, 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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Ken Kato, MD/PhD

  National Cancer Center Hospital

  STUDY CHAIR

Central Study Contacts

Motoo Nomura, MD/PhD

CONTACT

81335422511; mnomura@kuhp.kyoto-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Cancer Center Hospital

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 1, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

JP (1)