Localized Squamous Cell Carcinoma of the EsophagusPhase 2NCT02017600
A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus
A Phase 2 study testing ND-420, Surgery and Cisplatin in people with Localized Squamous Cell Carcinoma of the Esophagus, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial summary
Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Localized Squamous Cell Carcinoma of the Esophagus
- What is being tested?
- ND-420, Surgery and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to 4 Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
- The tumor had to be locally advanced (stage T2-3/N0, T1-3/N+, if technically resectable with curative intent).
- Patients must be 20 years of age.
- Patients must have an ECOG performance status score 2.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must be accessible for treatment and follow-up at least for one year.
- Patients must sign the informed consent form.
- Patient must have:Hemoglobin level 9 g/dl; Neutrophil count 1,500/mm3; Platelets count 100,000/mm3; Serum bilirubin level 1.0 ULN; Serum transaminase (GOT, GPT) levels 2.0 ULN; Serum Alkaline phosphatase levels 2.0 ULN; Serum creatinine level 1.5 mg/dl or Creatinine clearance rate(CrCl)60 ml/min for the institution (calculated by the Cockcroft- Gault equation).
Who cannot join
- Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
- Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
- Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.
- Patients with CNS metastasis, including clinical suspicion.
- Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.
- Mental statuses of patients are not fit for clinical trial.
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- Fertile men and women unless using a reliable and appropriate contraceptive method.
- Patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
- Patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:Active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; Uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); Retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); History of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.
- Being tested
- ND-420, Surgery, Cisplatin, fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND-420Drug
Also called ND-420(Nangkuang)
ND-420 50 mg/m2 on day1
SurgeryProcedure or surgery
After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.
CisplatinDrug
cisplatin 70 mg/m2 on day1
fluorouracilDrug
Also called 5-FU
fluorouracil 700 mg/m2 daily, day1 to day4
| Study group | Role | What they receive |
|---|---|---|
| Induction Chemotherapy DCF followed by Surgery | Experimental | All eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles. After induction chemotherapy, patients will be planned to receive Surgery. Receives: Drug: ND-420; Procedure: Surgery; Drug: Cisplatin; Drug: fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the R0 resection rate of participants
Measured: up to three months
Secondary outcomes (8)
the response rate (RECIST) of participants
Measured: up to three months
Number of participants with adverse events as a measure of safety and tolerability
Measured: up to one year
the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants
Measured: 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion.
the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response
Measured: up to one year
1-year survival rate of participants
Measured: up to one year
pathologic complete response rate of participants
Measured: up to one year
1-year progression free survival rate of participants
Measured: up to one year
1-year overall survival rate of participants
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startAug 2013
- Primary completion2 Dec 2014
- Study completion4 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Squamous Cell Carcinoma of the EsophagusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming-Huang Chen, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017600
- Sponsor's protocol ID
- NKCND420/201112
- Status last verified
- May 2020
- First submitted
- 9 Dec 2013
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus
- ClinicalTrials.gov ID
- NCT02017600
- Acronym / sponsor ID
- NKCND420/201112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 2 Dec 2014 (actual)
- Study completion
- 4 Apr 2015 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction Chemotherapy DCF followed by Surgery | Experimental | Drug: ND-420, Procedure: Surgery, Drug: Cisplatin, Drug: fluorouracilAll eligible patients will receive ND-420, Cisplatin and fluorouracil every 3 weeks for 2 cycles. After induction chemotherapy, patients will be planned to receive Surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
- The tumor had to be locally advanced (stage T2-3/N0, T1-3/N+, if technically resectable with curative intent).
- Patients must be 20 years of age.
- Patients must have an ECOG performance status score 2.
- Patients must have a life expectancy of at least 12 weeks.
Key exclusion criteria (9 listed)
- Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
- Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
- Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.
- Patients with CNS metastasis, including clinical suspicion.
- Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.
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 |
|---|---|---|
| ND-420Also: ND-420(Nangkuang)ND-420 50 mg/m2 on day1 | Drug | Induction Chemotherapy DCF followed by Surgery |
| SurgeryAfter induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy. | Procedure or surgery | Induction Chemotherapy DCF followed by Surgery |
| Cisplatincisplatin 70 mg/m2 on day1 | Drug | Induction Chemotherapy DCF followed by Surgery |
| fluorouracilAlso: 5-FUfluorouracil 700 mg/m2 daily, day1 to day4 | Drug | Induction Chemotherapy DCF followed by Surgery |
Primary outcome
the R0 resection rate of participants
Time frame: up to three months
8 secondary outcomes
the response rate (RECIST) of participants
Time frame: up to three months
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to one year
the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants
Time frame: 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion.
the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response
Time frame: up to one year
1-year survival rate of participants
Time frame: up to one year
pathologic complete response rate of participants
Time frame: up to one year
1-year progression free survival rate of participants
Time frame: up to one year
1-year overall survival rate of participants
Time frame: up to one year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
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. This study is not recruiting at the moment.
Ming-Huang Chen, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ND-420, Surgery and Cisplatin in people with Localized Squamous Cell Carcinoma of the Esophagus, run by Nang Kuang Pharmaceutical Co., Ltd. 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 May 2020. 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 phase mean?
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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the R0 resection rate of participants (time frame: up to three months). 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 20 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.