Esophageal CancerPhase 2NCT02375581
Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
A Phase 2 study testing Icotinib and Thoracic radiotherapy in people with Esophageal Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Icotinib and Thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002
Bing Xia, MD, 86 571 56006388, bxia_hzch@hotmail.com
About this study
Official title: A Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Icotinib, Thoracic radiotherapy
- Keywords
- Radiotherapy, Icotinib
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Conmana
125mg, Po, TID during RT
Thoracic radiotherapyRadiation
involved-Field irradiaton without elective nodal irradiation
| Study group | Role | What they receive |
|---|---|---|
| Icotinib & Radiotherapy | Experimental | Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT. Receives: Drug: Icotinib; Radiation: Thoracic radiotherapy |
| Radiotherapy alone | Active comparator | Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT. Receives: Radiation: Thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 2 years
Secondary outcomes (1)
incidence rates of radiation-related pneumonitis and esophagitis
Measured: within the 3 months after the initiation of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shixiu Wu, MD, Principal investigator, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375581
- Sponsor's protocol ID
- HZFH CA15-01
- Status last verified
- Mar 2016
- First submitted
- 16 Feb 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33026449
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02375581
- Acronym / sponsor ID
- HZFH CA15-01
- Conditions
- Esophageal Cancer
- Keywords
- Radiotherapy, Icotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icotinib & Radiotherapy | Experimental | Drug: Icotinib, Radiation: Thoracic radiotherapyIcotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT. |
| Radiotherapy alone | Active comparator | Radiation: Thoracic radiotherapyThoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT. |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IcotinibAlso: Conmana125mg, Po, TID during RT | Drug | Icotinib & Radiotherapy |
| Thoracic radiotherapyinvolved-Field irradiaton without elective nodal irradiation | Radiation | Icotinib & Radiotherapy, Radiotherapy alone |
Primary outcome
all cause mortality
Time frame: 2 years
1 secondary outcome
incidence rates of radiation-related pneumonitis and esophagitis
Time frame: within the 3 months after the initiation of RT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Derived from this study: PubMed 33026449Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shixiu Wu, MD principal investigator
Hangzhou Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icotinib and Thoracic radiotherapy in people with Esophageal Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Xia, MD (86 571 64006039, bxia_hzch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.