Esophageal Cancer TNM Staging Primary Tumor (T) T4Phase 1/2NCT06531434
Establishing Best Treatment Strategy for T4 Esophageal Cancer
A Phase 1/2 study testing "Docetaxel", "Cisplatin", "fluorouracil", "Radiation" in people with Esophageal Cancer TNM Staging Primary Tumor (T) T4, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer TNM Staging Primary Tumor (T) T4
- What is being tested?
- "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 30 Apr 2026
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed esophageal squamous cell carcinoma
- Tumor or lymph nodes invade adjacent organs (T4 stage)
- Aged between 18-70 years old
- Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2
- Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10^3/L, platelet count ≥ 100×10^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.
Who cannot join
- Previous chemotherapy history
- Myocardial infarction within the last three months
- History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
- Has other malignancies currently
- Uncontrolled infection
- Pregnancy or lactation
- Perforated esophagus at the time of diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan, 704302
Wei-Lun Chang, PhD, +886-6-2353535 ext. 4859, weilun1@mail.ncku.edu.tw
Ching-Lin Wu, Master, +886-6-2353535 ext. 3458, n027174@mail.hosp.ncku.edu.tw
About this study
Official title: A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are:
- Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate?
- Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer.
Read more
Participants will:
- Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3
- Visit the clinic once every week for checkups and tests
- Keep a diary of their symptoms
Read the detailed description
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.
- Being tested
- "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"
- Keywords
- T4 esophageal cancer, Induction chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Docetaxel", "Cisplatin", "fluorouracil", "Radiation"Combination product
Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy followed by chemoradiotherapy | Experimental | This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy. Receives: Combination Product: "Docetaxel", "Cisplatin", "fluorouracil", "Radiation" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate of the treatment
Overall response rate = complete response (CR) rate + partial response (PR) rate.
Measured: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Duration of response (DOR)
Defined as the time from CR or PR to the time of disease progression or death.
Measured: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Secondary outcomes (4)
Esophageal perforation rate
Detected by bronchoscopy or CT scan.
Measured: At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.
Adverse events of treatment
Any adverse events of chemotherapy or CCRT.
Measured: During treatment (up to 24 weeks)
Progression-free survival
Defined as the time from diagnosis to the time of disease progression or death.
Measured: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Overall survival time
Defined as the time from diagnosis to the time of death.
Measured: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal Cancer TNM Staging Primary Tumor (T) T4Studies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive an induction chemotherapy regimen consisting of 4-8 cycles of docetaxel, cisplatin, and fluorouracil. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531434
- Sponsor's protocol ID
- A-BR-113-045
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Results will be published by the investigators in academic journals.
Publications
Chan WL, Choi CW, Wong IY, Tsang TH, Lam AT, Tse RP, Chan KK, Wong C, Law BT, Cheung EE, Chan SY, Lam KO, Kwong D, Law S. Docetaxel, Cisplatin, and 5-FU Triplet Therapy as Conversion Therapy for Locoregionally Advanced Unresectable Esophageal Squamous Cell Carcinoma. Ann Surg Oncol. 2023 Feb;30(2):861-870. doi: 10.1245/s10434-022-12694-8. Epub 2022 Oct 28.
PubMed 36307666Satake H, Tahara M, Mochizuki S, Kato K, Hara H, Yokota T, Kiyota N, Kii T, Chin K, Zenda S, Kojima T, Bando H, Yamazaki T, Iwasa S, Honma Y, Hamauchi S, Tsushima T, Ohtsu A. A prospective, multicenter phase I/II study of induction chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma. Cancer Chemother Pharmacol. 2016 Jul;78(1):91-9. doi: 10.1007/s00280-016-3062-2. Epub 2016 May 18.
PubMed 27193097Makino T, Yamasaki M, Miyazaki Y, Wada N, Takahashi T, Kurokawa Y, Nakajima K, Takiguchi S, Mori M, Doki Y. Utility of initial induction chemotherapy with 5-fluorouracil, cisplatin, and docetaxel (DCF) for T4 esophageal cancer: a propensity score-matched analysis. Dis Esophagus. 2018 Apr 1;31(4). doi: 10.1093/dote/dox130.
PubMed 29190316
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06531434
- Acronym / sponsor ID
- A-BR-113-045
- Keywords
- T4 esophageal cancer, Induction chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 1 Aug 2024 (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.
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are:
- Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate?
- Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer.
Participants will:
- Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3
- Visit the clinic once every week for checkups and tests
- Keep a diary of their symptoms
Detailed description
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive an induction chemotherapy regimen consisting of 4-8 cycles of docetaxel, cisplatin, and fluorouracil. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy followed by chemoradiotherapy | Experimental | Combination Product: "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed esophageal squamous cell carcinoma
- Tumor or lymph nodes invade adjacent organs (T4 stage)
- Aged between 18-70 years old
- Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2
- Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10^3/L, platelet count ≥ 100×10^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.
Key exclusion criteria (7 listed)
- Previous chemotherapy history
- Myocardial infarction within the last three months
- History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
- Has other malignancies currently
- Uncontrolled infection
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 |
|---|---|---|
| "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"Induction chemotherapy with Docetaxel, Cisplatin, and fluorouracil for 4 to 8 cycles, followed by concurrent chemoradiotherapy with Cisplatin and Radiation 30.6-40 Gy. | Combination product | Induction chemotherapy followed by chemoradiotherapy |
Primary outcome
Overall response rate of the treatment
Time frame: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Overall response rate = complete response (CR) rate + partial response (PR) rate.
Duration of response (DOR)
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Defined as the time from CR or PR to the time of disease progression or death.
4 secondary outcomes
Esophageal perforation rate
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.
Adverse events of treatment
Time frame: During treatment (up to 24 weeks)
Progression-free survival
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Overall survival time
Time frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
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 Sep 2025.
- Background: PubMed 36307666Chan WL, Choi CW, Wong IY, Tsang TH, Lam AT, Tse RP, Chan KK, Wong C, Law BT, Cheung EE, Chan SY, Lam KO, Kwong D, Law S. Docetaxel, Cisplatin, and 5-FU Triplet Therapy as Conversion Therapy for Locoregionally Advanced Unresectable Esophageal Squamous Cell Carcinoma. Ann Surg Oncol. 2023 Feb;30(2):861-870. doi: 10.1245/s10434-022-12694-8. Epub 2022 Oct 28.
- Background: PubMed 27193097Satake H, Tahara M, Mochizuki S, Kato K, Hara H, Yokota T, Kiyota N, Kii T, Chin K, Zenda S, Kojima T, Bando H, Yamazaki T, Iwasa S, Honma Y, Hamauchi S, Tsushima T, Ohtsu A. A prospective, multicenter phase I/II study of induction chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma. Cancer Chemother Pharmacol. 2016 Jul;78(1):91-9. doi: 10.1007/s00280-016-3062-2. Epub 2016 May 18.
- Background: PubMed 29190316Makino T, Yamasaki M, Miyazaki Y, Wada N, Takahashi T, Kurokawa Y, Nakajima K, Takiguchi S, Mori M, Doki Y. Utility of initial induction chemotherapy with 5-fluorouracil, cisplatin, and docetaxel (DCF) for T4 esophageal cancer: a propensity score-matched analysis. Dis Esophagus. 2018 Apr 1;31(4). doi: 10.1093/dote/dox130.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Results will be published by the investigators in academic journals.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing "Docetaxel", "Cisplatin", "fluorouracil", "Radiation" in people with Esophageal Cancer TNM Staging Primary Tumor (T) T4, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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 Sep 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 Taiwan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wei-Lun Chang, PhD (+886-6-2353535 ext. 4859, weilun1@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate of the treatment (time frame: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06531434, which also lists 3 linked publications.
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 Sep 2025.