Advanced Esophageal Squamous CarcinomaPhase 2NCT01051765
Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
A Phase 2 study testing irinotecan/cisplatin in people with Advanced Esophageal Squamous Carcinoma, run by Peking University at 1 site in China.
Trial summary
Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Esophageal Squamous Carcinoma
- What is being tested?
- irinotecan/cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Aug 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed informed consent
- Age 18 to 70 years old
- Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
- Unresectable recurrent or metastatic disease
- Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
- Karnofsky performance status ≥70
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- Life expectancy of ≥3 month
- No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
- Serum AKP < 2.5 times ULN (within 7 days before enrollment)
- Serum creatinine <1.0 times ULN (within 7 days before enrollment)
- Bilirubin level < 1.0 times ULN (within 7 days before enrollment)
- WBC>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl(within 7 days before enrollment)
- No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃；
- Good compliance
Who cannot join
- previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
- Known hypersensitivity to irinotecan
- Only with Brain or bone metastasis
- Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
- No measurable lesions, eg. pleural fluid and ascites
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
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- Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
- Pregnancy or lactation period
- Other previous malignancy within 5 year, except non-melanoma skin cancer
- Chronic diarrhea
- Mentally abnormal or disable cognition,including CNS metastasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhang Xiaodong
Beijing, Beijing Municipality, 100142
zhang xiaodong, MD, 86-10-88196175, zxd0829@yahoo.com.cn
About this study
Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.
- Conditions
- Advanced Esophageal Squamous Carcinoma
- Being tested
- irinotecan/cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecan/cisplatinDrug
irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| irinotecan/cisplatin | Experimental | irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks Receives: Drug: irinotecan/cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 2 year
Secondary outcomes (4)
PFS
Measured: 1year
response rate
Measured: 1.5 months
adverse events
Measured: 2 year
polymorphism of UGT1A
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051765
- Sponsor's protocol ID
- IP-AEC1
- Status last verified
- May 2009
- First submitted
- 19 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01051765
- Acronym / sponsor ID
- IP-AEC1
- Conditions
- Advanced Esophageal Squamous Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 20 Jan 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.
Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irinotecan/cisplatin | Experimental | Drug: irinotecan/cisplatinirinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Having signed informed consent
- Age 18 to 70 years old
- Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
- Unresectable recurrent or metastatic disease
- Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
Key exclusion criteria (11 listed)
- previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
- Known hypersensitivity to irinotecan
- Only with Brain or bone metastasis
- Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
- No measurable lesions, eg. pleural fluid and ascites
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 |
|---|---|---|
| irinotecan/cisplatinirinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks | Drug | irinotecan/cisplatin |
Primary outcome
overall survival
Time frame: 2 year
4 secondary outcomes
PFS
Time frame: 1year
response rate
Time frame: 1.5 months
adverse events
Time frame: 2 year
polymorphism of UGT1A
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
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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.
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 irinotecan/cisplatin in people with Advanced Esophageal Squamous Carcinoma, run by Peking University 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 15 inclusion and 11 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 20 Jan 2010. 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 zhang xiaodong, MD (86-01-88196175, zxd0829@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2 year). 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 20 Jan 2010.