ARMADILLO: A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chemoradiation therapy with elective nodal irradiation 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
Chemoradiotherapy
|
| Active Comparator: Chemoradiation therapy with involved field irradiation 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
Chemoradiotherapy
|
Outcome Measures
Primary Outcome Measures
- Major progression-free survival [The primary analysis will be held 5-years after the last patient was enrolled.]
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.
Secondary Outcome Measures
- Overall survival [The primary analysis will be held 5-years after the last patient was enrolled.]
From date of randomization to date of death, approximately 5 years.
- Progression-free survival [The primary analysis will be held 5-years after the last patient was enrolled.]
From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.
- Complete response rate [The primary analysis will be held 5-years after the last patient was enrolled.]
CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.
- Esophagectomy-free survival [The primary analysis will be held 5-years after the last patient was enrolled.]
From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.
- Adverse events [The primary analysis will be held 5-years after the last patient was enrolled.]
Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0
- Long term toxicity [The primary analysis will be held 5-years after the last patient was enrolled.]
Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Center Hospital | Tokyo | Japan |
Sponsors and Collaborators
- National Cancer Center, Japan
Investigators
- Study Chair: Ken Kato, MD/PhD, National Cancer Center Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JCOG1904