Squamous Cell Carcinoma of EsophagusPhase 2NCT02033538
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
A Phase 2 study testing nanoparticle albumin-bound paclitaxel in people with Squamous Cell Carcinoma of Esophagus, run by Zhejiang University at 1 site in China.
Trial summary
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Carcinoma of Esophagus
- What is being tested?
- nanoparticle albumin-bound paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
- Locally advanced disease that is technically operable with curative intent (R0)
- T3, N0 OR T1-3, N+ OR T4, Nx
- No T1-2, N0
- No inoperable T4 (unequivocal organ involvement)
- No distant metastasis, including M1a lymph node status
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- Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
- No carcinoma of the cervical esophagus
- Obstructive tumors allowed
Who cannot join
- Not suitable to surgery
- cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- early Esophageal Carcinoma(Stage I)
- complete esophageal obstruction，Esophageal perforation or hematemesis
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
- pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
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- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- History of serious allergic or castor oil allergy
- Patients who are not suitable to participate in the trial according to researchers
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.
Read the detailed description
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.
- Conditions
- Squamous Cell Carcinoma of Esophagus
- Being tested
- nanoparticle albumin-bound paclitaxel
- Keywords
- Neoadjuvant chemotherapy, Nab-Paclitaxel, Carcinoma of Esophagus
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticle albumin-bound paclitaxelDrug
Also called nab-paclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| nanoparticle albumin-bound paclitaxel | Experimental | Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle Receives: Drug: nanoparticle albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
pathological response rate and clinical response rate
Measured: From date of treatment until the date of progression, assessed up to 2 months
Secondary outcomes (3)
Overall survival
Measured: Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months
Progression-free survival
Measured: Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months
Adverse events
Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0
Measured: During the chemotherapy,an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: This clinical trial was closed due to slow recruitment of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of EsophagusStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiong Zhao, Zhejiang University
- Investigators
- Qiong Zhao, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033538
- Sponsor's protocol ID
- ZYTOP1403
- Status last verified
- Mar 2015
- First submitted
- 16 Dec 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
- ClinicalTrials.gov ID
- NCT02033538
- Acronym / sponsor ID
- ZYTOP1403
- Conditions
- Squamous Cell Carcinoma of Esophagus
- Keywords
- Neoadjuvant chemotherapy, Nab-Paclitaxel, Carcinoma of Esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This clinical trial was closed due to slow recruitment of patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jan 2014 (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.
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.
Detailed description
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nanoparticle albumin-bound paclitaxel | Experimental | Drug: nanoparticle albumin-bound paclitaxelPaclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
- Locally advanced disease that is technically operable with curative intent (R0)
- T3, N0 OR T1-3, N+ OR T4, Nx
- No T1-2, N0
- No inoperable T4 (unequivocal organ involvement)
Key exclusion criteria (9 listed)
- Not suitable to surgery
- cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- early Esophageal Carcinoma(Stage I)
- complete esophageal obstruction，Esophageal perforation or hematemesis
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
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 |
|---|---|---|
| nanoparticle albumin-bound paclitaxelAlso: nab-paclitaxelPaclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle | Drug | nanoparticle albumin-bound paclitaxel |
Primary outcome
response rate
Time frame: From date of treatment until the date of progression, assessed up to 2 months
pathological response rate and clinical response rate
3 secondary outcomes
Overall survival
Time frame: Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months
Progression-free survival
Time frame: Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months
Adverse events
Time frame: During the chemotherapy,an expected average of 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Qiong Zhao, MD principal investigator
First Affiliated Hospital of Zhejiang University
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 nanoparticle albumin-bound paclitaxel in people with Squamous Cell Carcinoma of Esophagus, run by Zhejiang 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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 5 Mar 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
response rate (time frame: From date of treatment until the date of progression, assessed up to 2 months). 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 5 Mar 2015.