Esophageal CancerPhase 1/2NCT02762474
Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer
A Phase 1/2 study testing nab-paclitaxel group in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- nab-paclitaxel group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2017
- Phase
- Phase 1/2
- 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
- inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
- ECOG performance status scale 0-1
- at least 1 measurable target lesions
- white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
- normal cardiac function with no severe heart disease.
Who cannot join
- history of esophagectomy
- pregnancy or breast feeding
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
- concomitant treatment with other anticancer drugs.
Trial locations and contacts
1 site in 1 country.
Ping Wang, M. D. contact
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Ping Wang, M. D., 08623340123-1141, wangping@tjmuch.com
About this study
Official title: A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma
This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.
Read the detailed description
Esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. Concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. Paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. Compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. According to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.
- Conditions
- Esophageal Cancer
- Being tested
- nab-paclitaxel group
- Keywords
- nab-paclitaxel, IMRT, 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.
nab-paclitaxel groupDrug
Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel group | Experimental | Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT Receives: Drug: nab-paclitaxel group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Measured: 3 years
Secondary outcomes (2)
Overall survival
Measured: 3 years
CTCAE 4.0 toxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2014
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (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 Tianjin Medical University Cancer Institute and 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Wang, M. D., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762474
- Sponsor's protocol ID
- ESO20140703
- Status last verified
- Mar 2016
- First submitted
- 3 May 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT02762474
- Acronym / sponsor ID
- ESO20140703
- Conditions
- Esophageal Cancer
- Keywords
- nab-paclitaxel, IMRT, esophageal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 May 2016 (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.
This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.
Detailed description
Esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. Concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. Paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. Compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. According to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel group | Experimental | Drug: nab-paclitaxel groupWeekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
- ECOG performance status scale 0-1
- at least 1 measurable target lesions
- white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
- normal cardiac function with no severe heart disease.
Key exclusion criteria (4 listed)
- history of esophagectomy
- pregnancy or breast feeding
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
- concomitant treatment with other anticancer drugs.
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 |
|---|---|---|
| nab-paclitaxel groupWeekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT | Drug | nab-paclitaxel group |
Primary outcome
Progress free survival
Time frame: 3 years
2 secondary outcomes
Overall survival
Time frame: 3 years
CTCAE 4.0 toxicity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ping Wang, M. D. contact
Ping Wang, M. D. principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nab-paclitaxel group in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and 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 5 inclusion and 4 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 7 Feb 2017. 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 combined 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.
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 Ping Wang, M. D. (0862223340123, wangping@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: 3 years). 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 7 Feb 2017.