Clinical trial NCT02969473: Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma
Official title: Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma: a Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasm
Chemoradiation
Keywords: esophageal squamous cell carcinoma
concurrent chemoradiotherapy
docetaxel
cisplatin
5-fluorouracil
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Detailed description: Esophageal cancer is one of the most fatal malignancies worldwide. Radical surgery has been the primary treatment for patients with resectable esophageal cancer. For medically unfit patients or medically fit patients who decline surgery, definitive radiotherapy plus concurrent chemotherapy has been established as a standard treatment. Since the 1980' s, the most widely used chemotherapeutic regimen in combination with radiotherapy for esophageal cancer was cisplatin (CDDP) plus 5-fluorouracil (5-FU) (the PF regimen). However, locoregionally persistent or recurrent diseases were still quite common and survival remained poor. Several previous studies conducted by the radiation therapy oncology group (RTOG) explored the efficacy of radiation dose escalation, but all results turned out disappointing. And studies incorporating intensified PF regimen or new-generation cytotoxic agents such as paclitaxel and oxaliplatin did not show any advantage over the standard-dosage PF regimen either. In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Eligibility criteria: Inclusion Criteria:

* patients with histologically proven squamous cell carcinoma of the esophagus
* stage II-IVA disease, including metastatic celiac or cervical nodes, according to the sixth edition of American Joint Committee on Cancer (AJCC) staging system for esophageal cancer
* aged between 18 and 70 years
* Karnofsky Performance Status (KPS) score ≥ 70
* adequate bone marrow function (leukocyte count ≥ 4000/uL, platelet count ≥ 100,000/uL), adequate liver function (serum alanine aminotransferase (ALT) level and serum aspartate aminotransferase (AST) level \< twice the upper limit of normal, and serum bilirubin level of \<1.5 mg/dL), and adequate renal function (creatinine clearance ≥ 50 mL/min)
* no other serious medical conditions
* life expectancy ≥ 3 months
* written informed consent

Exclusion Criteria:

* detection of distant metastasis (excluding metastatic celiac or cervical nodes) before treatment before treatment
* known allergy to CDDP, 5-FU, or docetaxel
* pregnancy or breast feeding

Primary outcomes:
measure: Overall survival (OS)
timeFrame: From the date of randomization until the date of death, up to 5 years.
Secondary outcomes:
measure: Treatment response rate
timeFrame: From the date of randomization until six weeks after treatment completion.
measure: Progress Free Survival (PFS)
timeFrame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
measure: Acute treatment-related toxicities
timeFrame: From the date of randomization until six months after treatment completion.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SYSU Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yonghong Hu, MD
role: PRINCIPAL_INVESTIGATOR
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