Esophageal CancerPhase 2NCT01291823
Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer
A Phase 2 study testing gefitinib and Thoracic radiotherapy in people with Esophageal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib. 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?
- gefitinib and Thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 2014
- 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
- Histologically documented diagnosis of esophageal Cancer
- Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible
- age:70-85 years
- Written informed consent.
- Performance status of 0 to 2
- Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L.
- Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement
- Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
Who cannot join
- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy or radiation therapy for esophageal cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xu yaping, MD, 0086-571-88122, xuyaping1207@gmail.com
About this study
Official title: A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.
Read the detailed description
Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and thoracic radiation in elderly patients with esophageal Cancer.
Methods:Patients(>70 years old) with esophageal Cancer will receive thoracic radiation therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.
- Conditions
- Esophageal Cancer
- Being tested
- gefitinib, Thoracic radiotherapy
- Keywords
- gefitinib, radiation, esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
gefitinib 250mg/day
Thoracic radiotherapyRadiation
Thoracic radiotherapy 54-60Gy over 30 fraction
| Study group | Role | What they receive |
|---|---|---|
| Concomitant Gefitinib and radiotherapy | Experimental | Patients received Gefitinib and radiation therapy Receives: Drug: gefitinib; Radiation: Thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Measured: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment
Secondary outcomes (1)
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mao Weimin, MD, Principal investigator, Zhejiang Cancer HospitalXu yaping, MD, Principal investigator, 0086-571-88122082
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291823
- Sponsor's protocol ID
- ZhejiangCH10
- Status last verified
- Feb 2011
- First submitted
- 4 Feb 2011
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
- ClinicalTrials.gov ID
- NCT01291823
- Acronym / sponsor ID
- ZhejiangCH10
- Conditions
- Esophageal Cancer
- Keywords
- gefitinib, radiation, esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Feb 2011 (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.
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.
Detailed description
Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and thoracic radiation in elderly patients with esophageal Cancer.
Methods:Patients(>70 years old) with esophageal Cancer will receive thoracic radiation therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concomitant Gefitinib and radiotherapy | Experimental | Drug: gefitinib, Radiation: Thoracic radiotherapyPatients received Gefitinib and radiation therapy |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Histologically documented diagnosis of esophageal Cancer
- Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible
- age:70-85 years
- Written informed consent.
- Performance status of 0 to 2
Key exclusion criteria (3 listed)
- Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Prior systemic chemotherapy or radiation therapy for esophageal cancer
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 |
|---|---|---|
| gefitinibgefitinib 250mg/day | Drug | Concomitant Gefitinib and radiotherapy |
| Thoracic radiotherapyThoracic radiotherapy 54-60Gy over 30 fraction | Radiation | Concomitant Gefitinib and radiotherapy |
Primary outcome
Tumor response rate
Time frame: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment
1 secondary outcome
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
Time frame: 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
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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.
Mao Weimin, MD principal investigator
Zhejiang Cancer Hospital
Xu yaping, MD principal investigator
0086-571-88122082
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 gefitinib and Thoracic radiotherapy in people with Esophageal Cancer, run by Zhejiang Cancer Hospital 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 8 inclusion and 3 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 8 Feb 2011. 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 Mao Weimin, MD (0086-571-88122222, maowmzj1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (time frame: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2011.