Clinical trial NCT02375581: Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
Official title: A Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Radiotherapy
Icotinib
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 130
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.

Detailed description: Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including surgery or concurrent chemoradiotherapy. EGFR is overexposed in most of the cases. In this phase II trial, the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy will be investigated in this setting.

Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed esophageal carcinoma
2. Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy
3. Aged ≥ 70 and \< 85 years, behavioral status evaluation ECOG scores 0-2
4. In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 80 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
5. Subjects should sign for the informed consent
6. Subjects should perform good compliance

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
4. Patients who have multiple foci esophageal carcinomas
5. Patients who are/were given any other medicine tests currently/in last 4 weeks
6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
7. Patients who have complications as following:

(1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.

Primary outcomes:
measure: all cause mortality
timeFrame: 2 years
Secondary outcomes:
measure: incidence rates of radiation-related pneumonitis and esophagitis
timeFrame: within the 3 months after the initiation of RT
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Hangzhou Cancer Hospital
name: Shixiu Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo H, Jiang W, Ma L, Chen P, Fang M, Ding L, Hua Y, Du D, Jing Z, Xie R, Song Y, Wang J, Zhou R, Tian Z, Wu S. Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019440. doi: 10.1001/jamanetworkopen.2020.19440.