Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964455
• Other study ID #: GASTO201610003
• Status: Completed
• Phase: Phase 1
• Start date: November 2016
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed esophageal squamous cell carcinoma

• Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.

• Eastern Cooperative Oncology Group (ECOG) performance status 1-2

• Estimated life expectancy of at least 12 weeks

• Charlson comorbidity index=4

• Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1

• Adequate renal function: creatinine grade 0 or 1

• Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit

• Weight loss=15% during 6 months prior to diagnosis

• Forced expiratory volume second=1L

Exclusion Criteria:

• Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ

• Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy

• Contraindication for chemotherapy or radiotherapy

• Malignant pleural or pericardial effusion

• Women in pregnancy or lactation period

• Women who has the probability of pregnancy without contraception

• Weight loss=15% during 3 months prior to diagnosis

• In other clinical trials within 30 days

• Addicted in drugs or alcohol, AIDS patients

• Uncontrollable seizure or psychotic patients without self-control ability

• Severe allergy or idiosyncrasy

• Not suitable for this study judged by researchers

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Docetaxel
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
• Nedaplatin
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation

Radiation:
• chest radiation
continuous chest radiation at 64 Gy/32f

Locations

Country	Name	City	State
China	Hui Liu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose limiting toxicity		From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Primary	Maximum tolerated dose		From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Secondary	Occurrence and severity of adverse events		From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Secondary	Clinical response rate		8 weeks after end of combination treatment
Secondary	Dynamic plasma concentration of docetaxel and nedaplatin		From start of week 1 to the end of combination treatment (6.5 weeks)