Clinical trial NCT02858206: Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma
Official title: Prospective, Non-randomised Phase Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Locally Advanced Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Keywords: Locally advanced esophageal cancer
Radiotherapy and nimotuzumab
Concurrent chemoradiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Hebei Medical University Fourth Hospital
name: Affiliated Hospital of Hebei University
name: Beijing Army General Hospital
name: Beijing Hospital
name: Peking University First Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: Henan Cancer Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Fujian Cancer Hospital
First posted: 2016-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.

Detailed description: In the era of IMRT and concurrent chemoradiotherapy, the 5-year overall survival of esophageal cancer increase from 10% to about 20%-40%, recurrence rate decrease from 80% to 50%-60%, and local recurrence remains to be the most important type of failure. What called for is to enhance local control without increasing toxicity to improve survival. The investigators have found effective and safe regimen of simultaneously integrated boost radiotherapy in previous study, which can achieve high dose in tumor area with avoid of normal tissues. However, a recent prospective study reported that neoadjuvant chemoradiotherapy resulted in much higher toxicities compares to neoadjuvant chemotherapy (46% vs. 15%, p= 0.04). Although chemoradiotherapy reached a higher pCR rate (28% vs. 9%, p=0.002), patients did not differ in survival in two groups.

Nimotuzumab is an humanized monoclonal antibody against EGFR. Radiotherapy combines Nimotuzumab reveals synergistic effect in head and neck cancers with lower toxicities as compared to concurrent chemoradiotherapy. Our previous study showed that EGFR expression rate were similar in esophageal cancer and head and neck cancers. Based on above results, the investigators design this study which aims to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinical stage T1-4aN0-1M1a untreated squamous esophageal carcinoma
* KPS≥70
* Adequate organ function
* No known history of drug allergy

Exclusion Criteria:

* Known drug allergy
* Insufficient hepatorenal function
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Primary outcomes:
measure: Pathological response rate
timeFrame: Up to 1 year
measure: Pathological lymph node metastases rate
timeFrame: Up to 1 year
measure: R0 resection rate
timeFrame: Up to 1 year
measure: Adverse events
timeFrame: Up to 2 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: Recurrence rate
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zefen Xiao
state: Beijing
Study officials:
References:
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