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

Esophageal Squamous Cell Carcinoma Clinical Trial

— ARMADILLO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328948
• Other study ID #: JCOG1904
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: March 31, 2030

Study information

• Verified date: November 2023
• Source: National Cancer Center, Japan
• Contact: Motoo Nomura, MD/PhD
• Phone: 81335422511
• Email: mnomura[@]kuhp.kyoto-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 31, 2030
• Est. primary completion date: March 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

1. Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.

2. 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.

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. Written informed consent is obtained.

Exclusion criteria:

1. Simultaneous or metachronous (within 5 years) double cancers, except for 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 post parturition, or during lactation. Male who wants a partner's pregnancy.

5. Psychological disorder, which is 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, which is uncontrollable with continuous use of insulin 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 drugs.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• Chemoradiotherapy
Chemoradiotherapy

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	From date of randomization to date of death, approximately 5 years.	The primary analysis will be held 5-years after the last patient was enrolled.
Secondary	Progression-free survival	From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.	The primary analysis will be held 5-years after the last patient was enrolled.
Secondary	Complete response rate	CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.	The primary analysis will be held 5-years after the last patient was enrolled.
Secondary	Esophagectomy-free survival	From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.	The primary analysis will be held 5-years after the last patient was enrolled.
Secondary	Adverse events	Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0	The primary analysis will be held 5-years after the last patient was enrolled.
Secondary	Long term toxicity	Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0	The primary analysis will be held 5-years after the last patient was enrolled.