NCT02375581

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

February 16, 2015

Last Update Submit

March 18, 2016

Conditions

Esophageal Cancer

Keywords

RadiotherapyIcotinib

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    2 years

Secondary Outcomes (1)

  • incidence rates of radiation-related pneumonitis and esophagitis

    within the 3 months after the initiation of RT

Study Arms (2)

Icotinib & Radiotherapy

EXPERIMENTAL

Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT.

Drug: IcotinibRadiation: Thoracic radiotherapy

Radiotherapy alone

ACTIVE COMPARATOR

Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT.

Radiation: Thoracic radiotherapy

Interventions

IcotinibDRUG

125mg, Po, TID during RT

Also known as: Conmana
Icotinib & Radiotherapy
Thoracic radiotherapyRADIATION

involved-Field irradiaton without elective nodal irradiation

Icotinib & RadiotherapyRadiotherapy alone

Eligibility Criteria

Age70 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Pathologically confirmed esophageal carcinoma
  • Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy
  • Aged ≥ 70 and \< 85 years, behavioral status evaluation ECOG scores 0-2
  • 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
  • Subjects should sign for the informed consent
  • Subjects should perform good compliance

You may not qualify if:

  • Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
  • Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  • 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
  • Patients who have multiple foci esophageal carcinomas
  • Patients who are/were given any other medicine tests currently/in last 4 weeks
  • Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310002, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33026449DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

icotinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Shixiu Wu, MD

    Hangzhou Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xia, MD

CONTACT

86 571 64006039bxia_hzch@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 2, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

CN(1)