Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Sun Yat-sen University

Status and phase: Completed; Phase 1

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Nedaplatin; Drug: Docetaxel; Radiation: chest radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02964455

GASTO201610003

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Docetaxel + Nedaplatin + Radiotherapy

Experimental group

Description:

Docetaxel and 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.

Treatment:

Drug: Docetaxel

Drug: Nedaplatin

Radiation: chest radiation