Localized Squamous Cell Carcinoma of the Esophagus Clinical Trial
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
| Verified date | May 2020 |
| Source | Nang Kuang Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 48 |
| Est. completion date | April 4, 2015 |
| Est. primary completion date | December 2, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taipei Veterans General Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Nang Kuang Pharmaceutical Co., Ltd. |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the R0 resection rate of participants | up to three months | ||
| Secondary | the response rate (RECIST) of participants | up to three months | ||
| Secondary | Number of participants with adverse events as a measure of safety and tolerability | up to one year | ||
| Secondary | the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants | 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion. | ||
| Secondary | 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 | up to one year | ||
| Secondary | 1-year survival rate of participants | up to one year | ||
| Secondary | pathologic complete response rate of participants | up to one year | ||
| Secondary | 1-year progression free survival rate of participants | up to one year | ||
| Secondary | 1-year overall survival rate of participants | up to one year |