Clinical trial NCT02964455: Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal squamous cell carcinoma
Chemoradiotherapy
Docetaxel
Nedaplatin
Twice weekly
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of dose limiting toxicity
timeFrame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
measure: Maximum tolerated dose
timeFrame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Secondary outcomes:
measure: Occurrence and severity of adverse events
timeFrame: From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)
measure: Clinical response rate
timeFrame: 8 weeks after end of combination treatment
measure: Dynamic plasma concentration of docetaxel and nedaplatin
timeFrame: From start of week 1 to the end of combination treatment (6.5 weeks)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hui Liu
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: