Esophageal CancerPhase 1NCT01175447
S-1 and Radiotherapy in Elderly Patients With Esophageal Cancer
A Phase 1 study testing S-1 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 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day. 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?
- S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 1
- 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.
About this study
Official title: A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.
Read the detailed description
Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase II study when administered concurrently with thoracic radiation in elderly patients (>70 years old) with esophageal Cancer.
Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times weekly to a total dose of 54 Gy.
- Conditions
- Esophageal Cancer
- Being tested
- S-1
- Keywords
- S-1, 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.
S-1Drug
S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy with S-1 | Experimental | radiation 54Gy over 30 fractions,and concurrent with s-1 on days 1-14 and 29-42 Receives: Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
Measured: 3 months per patient
Secondary outcomes (1)
Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]).
Measured: dependent upon results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JYongling, Zhejiang Cancer Hospital
- Investigators
- Xianghui Du, MD, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175447
- Sponsor's protocol ID
- ZhejiangCH07
- Status last verified
- Mar 2012
- First submitted
- 31 Jul 2010
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ji Y, Qiu G, Sheng L, Sun X, Zheng Y, Chen M, Du X. A phase I dose escalation study of S-1 with concurrent radiotherapy in elderly patients with esophageal cancer. J Thorac Dis. 2016 Mar;8(3):451-8. doi: 10.21037/jtd.2016.02.70.
PubMed 27076940
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of S-1 With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01175447
- Acronym / sponsor ID
- ZhejiangCH07
- Conditions
- Esophageal Cancer
- Keywords
- S-1, radiation, esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Aug 2010 (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 54Gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.
Detailed description
Purpose:evaluated the dose-limiting toxicity and recommended dose of S-1 for a future phase II study when administered concurrently with thoracic radiation in elderly patients (>70 years old) with esophageal Cancer.
Methods:S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day. Thoracic radiation therapy was administered in 1.8Gy fractions five times weekly to a total dose of 54 Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy with S-1 | Experimental | Drug: S-1radiation 54Gy over 30 fractions,and concurrent with s-1 on days 1-14 and 29-42 |
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 |
|---|---|---|
| S-1S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day | Drug | Chemoradiotherapy with S-1 |
Primary outcome
Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer
Time frame: 3 months per patient
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
1 secondary outcome
Objective response rate (e.g. complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]).
Time frame: dependent upon results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Derived from this study: PubMed 27076940Ji Y, Qiu G, Sheng L, Sun X, Zheng Y, Chen M, Du X. A phase I dose escalation study of S-1 with concurrent radiotherapy in elderly patients with esophageal cancer. J Thorac Dis. 2016 Mar;8(3):451-8. doi: 10.21037/jtd.2016.02.70.
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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.
Xianghui Du, MD study chair
Zhejiang 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 1 study testing S-1 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: finished, as of the sponsor's last update on 6 Mar 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of s-1 in combination with thoracic radiotherapy in elderly patients (> 70 years old) with esophageal Cancer (time frame: 3 months per patient). 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 NCT01175447, 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 6 Mar 2012.