JCOG1904: A randomized controlled phase III trial of comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal cancer (ARMADILLO)
JCOG1904: A randomized controlled phase III trial of comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal cancer (ARMADILLO)
TSUSHIMA Takahiro
Shizuoka Cancer Center
1007, Naga-izumi, Suntogun, Shizuoka, 411-8777 Japan
+81-55-989-5222
t.tsushima@scchr.jp
TSUSHIMA Takahiro
Shizuoka Cancer Center
1007, Naga-izumi, Suntogun, Shizuoka, 411-8777 Japan
+81-55-989-5222
t.tsushima@scchr.jp
Recruiting
July. 14, 2020
July. 17, 2020
176
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
(1)Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
(2)All lesions located in the thoracic esophagus. Secondary lesions with absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
(3)Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
(4)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.
(5)Aged 20 years and older.
(6)ECOG Performance status 0 or 1.
(7)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.
(8)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.
(9)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,
(10)Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
(11)Witten informed consent is obtained.
(1)Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
(2)Active infection requiring systemic therapy.
(3)Fever over 38 degrees Celsius
(4)Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
(5)Psychological disorder difficult to participate in this clinical study.
(6)Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7)Positive for HBs antigen or HIV antigen.
(8)Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents.
(9)Uncontrolled arterial hypertension.
(10)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
(11)Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
(12)Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
(13)With a history of cerebrovascular disorder within 6 months.
(14)Drug allergy for iodic drug.
20age old over
No limit
Both
esophageal cancer
A:Chemoradiation therapy without additional prophylactic irradiation(JCOG0502 regimen).
Chemoradiotherapy consists of 5-FU (700 mg/m2, day1-4, day29-32), CDDP (70 mg/m2, day1,29) and radiotherapy (60 Gy/30Fr),
B:Chemoradiation therapy with additional prophylactic irradiation(JCOG0909 regimen)
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),
Salvage therapy including salvage endoscopic mucosal resection and endoscopic submucosal dissection is applied if the patient has residual tumor or recurrent tumor after definitive chemoradiotherapy.
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.
