Esophageal Squamous Cell CarcinomaPhase 3ARMADILLONCT04328948
A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC
A Phase 3 study testing Chemoradiotherapy in people with Esophageal Squamous Cell Carcinoma, run by National Cancer Center, Japan at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jul 2020to 31 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital
Tokyo
Ken Kato, M.D./Ph.D
About this study
Official title: A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer
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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Chemoradiotherapy
- Keywords
- Esophageal squamous cell carcinoma, chemoradiotherapy, Radiation Field
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiotherapyRadiation
Chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation therapy with elective nodal irradiation | Experimental | 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) Receives: Radiation: Chemoradiotherapy |
| Chemoradiation therapy with involved field irradiation | Active comparator | Chemoradiotherapy consists of 5-FU (700 mg /m2, day1-4, day29-32), CDDP (70 mg /m2, day1,29) and radiotherapy (60 Gy/30Fr) Receives: Radiation: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Secondary outcomes (6)
Overall survival
From date of randomization to date of death, approximately 5 years.
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Progression-free survival
From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Complete response rate
CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Esophagectomy-free survival
From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Adverse events
Number of participants with treatment-related adverse events during CRT as assessed by CTCAE v4.0
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Long term toxicity
Number of participants with treatment-related adverse events after termination of CRT as assessed by CTCAE v4.0
Measured: The primary analysis will be held 5-years after the last patient was enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Jul 2020
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ken Kato, National Cancer Center, Japan
- Investigators
- Ken Kato, MD/PhD, Study chair, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328948
- Sponsor's protocol ID
- JCOG1904
- Acronym
- ARMADILLO
- Status last verified
- May 2025
- First submitted
- 23 Mar 2020
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase III Trial of Comparing Local Field With Additional Prophylactic Irradiation in Chemoradiotherapy for Clinical-T1bN0M0 Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04328948
- Acronym / sponsor ID
- ARMADILLO / JCOG1904
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal squamous cell carcinoma, chemoradiotherapy, Radiation Field
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation therapy with elective nodal irradiation | Experimental | Radiation: ChemoradiotherapyChemoradiotherapy consists of 5-FU (1,000 mg / m2, day1-4, day29-32), CDDP (75 mg /m2, day1, 29) and radiotherapy (50.4 Gy/28Fr) |
| Chemoradiation therapy with involved field irradiation | Active comparator | Radiation: ChemoradiotherapyChemoradiotherapy consists of 5-FU (700 mg /m2, day1-4, day29-32), CDDP (70 mg /m2, day1,29) and radiotherapy (60 Gy/30Fr) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiotherapyChemoradiotherapy | Radiation | Chemoradiation therapy with elective nodal irradiation, Chemoradiation therapy with involved field irradiation |
Primary outcome
Major progression-free survival
Time frame: 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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ken Kato, MD/PhD study chair
National Cancer Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemoradiotherapy in people with Esophageal Squamous Cell Carcinoma, run by National Cancer Center, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Motoo Nomura, MD/PhD (81335422511, mnomura@kuhp.kyoto-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major progression-free survival (time frame: The primary analysis will be held 5-years after the last patient was enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.