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Recruiting NCT04328948

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

Phase III Interventional Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemoradiotherapy.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer

Overview

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.

Interventions

  • Radiation Chemoradiotherapy
    Chemoradiotherapy

Primary outcome measures

  • Major progression-free survival [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]
Secondary outcome measures (6)
  • Overall survival [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Progression-free survival [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Complete response rate [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Esophagectomy-free survival [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Adverse events [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]
  • Long term toxicity [Time frame: The primary analysis will be held 5-years after the last patient was enrolled.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 1 center
  • National Cancer Center Hospital — Tokyo

Identifiers

NCT: NCT04328948 · JCOG1904

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗