Esophageal CancerPhase 2NCT00154804
CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer
A Phase 2 study testing Paclitaxel, Cisplatin,Surgery, CCRT in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Paclitaxel, Cisplatin,Surgery, CCRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2001to Apr 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven SCC or adenocarcinoma of esophagus .
- Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
- M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
- Age ≧ 18 ys
- KPS ≧ 60%
- Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl .
Who cannot join
- Invasion to surrounding organ ( T4 disease ) .
- Distant metastasis , except M1a disease .
- Patients who refuse operation .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
Read the detailed description
The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Paclitaxel, Cisplatin,Surgery, CCRT
- Keywords
- Concurrent Chemoradiotherapy, 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.
Paclitaxel, Cisplatin,Surgery, CCRTDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Paclitaxel, Cisplatin,Surgery, CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and pathological response rates
Measured: 2000~2004
Secondary outcomes (3)
Progression free survival
Measured: 2000~2004
overall survival
Measured: 2000~2004
Toxicity
Measured: 2000~2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2001
- Study completionApr 2004
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 National Taiwan University 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chih-Hung Hsu, M.D.,Ph.D., Principal investigator, Department of Oncology, National Taiwan University HospitalAnn-Lii Cheng, M.D.,Ph.D, Study chair, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154804
- Sponsor's protocol ID
- 900603
- Status last verified
- Apr 2004
- First submitted
- 8 Sep 2005
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
PubMed 26313683
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00154804
- Acronym / sponsor ID
- 900603
- Conditions
- Esophageal Cancer
- Keywords
- Concurrent Chemoradiotherapy, Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Apr 2004 (actual)
- First posted
- 12 Sep 2005 (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.
CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
Detailed description
The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Paclitaxel, Cisplatin,Surgery, CCRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically proven SCC or adenocarcinoma of esophagus .
- Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
- M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
- Age ≧ 18 ys
- KPS ≧ 60%
Key exclusion criteria (3 listed)
- Invasion to surrounding organ ( T4 disease ) .
- Distant metastasis , except M1a disease .
- Patients who refuse operation .
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 |
|---|---|---|
| Paclitaxel, Cisplatin,Surgery, CCRT | Drug | A |
Primary outcome
Clinical and pathological response rates
Time frame: 2000~2004
3 secondary outcomes
Progression free survival
Time frame: 2000~2004
overall survival
Time frame: 2000~2004
Toxicity
Time frame: 2000~2004
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 23 Aug 2007.
- Derived from this study: PubMed 26313683Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
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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.
Chih-Hung Hsu, M.D.,Ph.D. principal investigator
Department of Oncology, National Taiwan University Hospital
Ann-Lii Cheng, M.D.,Ph.D study chair
Department of Oncology, National Taiwan University 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 Paclitaxel, Cisplatin,Surgery, CCRT in people with Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 23 Aug 2007. 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 Taiwan. 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?
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?
Clinical and pathological response rates (time frame: 2000~2004). 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 NCT00154804, 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 23 Aug 2007.