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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Chemoradiotherapy

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, chemoradiotherapy, Radiation Field

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Cancer Center HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemoradiation therapy with elective nodal irradiation

Chemoradiation therapy with involved field irradiation

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

From date of randomization to date of death, approximately 5 years.

Progression-free survival

From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.

Complete response rate

CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.

Esophagectomy-free survival

From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.

Adverse events

Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0

Long term toxicity

Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0

Full Information

NCT ID

NCT04328948

First Posted

March 23, 2020

Last Updated

April 5, 2022

Sponsor

National Cancer Center, Japan

1. Study Identification

Unique Protocol Identification Number

NCT04328948

Brief Title

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

Acronym

ARMADILLO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

March 31, 2030 (Anticipated)

Study Completion Date

March 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma, chemoradiotherapy, Radiation Field

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemoradiation therapy with elective nodal irradiation

Arm Type

Experimental

Arm Description

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)

Arm Title

Chemoradiation therapy with involved field irradiation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Chemoradiotherapy

Intervention Description

Chemoradiotherapy

Primary Outcome Measure Information:

Title

Major progression-free survival

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall survival

Description

From date of randomization to date of death, approximately 5 years.

Time Frame

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

Title

Progression-free survival

Description

From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.

Time Frame

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

Title

Complete response rate

Description

CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.

Time Frame

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

Title

Esophagectomy-free survival

Description

From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.

Time Frame

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

Title

Adverse events

Description

Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0

Time Frame

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

Title

Long term toxicity

Description

Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Motoo Nomura, MD/PhD

Phone

81335422511

mnomura@kuhp.kyoto-u.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ken Kato, MD/PhD

Organizational Affiliation

National Cancer Center Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

National Cancer Center Hospital

City

Tokyo

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ken Kato, M.D./Ph.D

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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