Esophageal CancerPhase 3NCT02461043
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma
A Phase 3 study testing paclitaxel; cisplatin and radiation in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases. 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 and radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2023
- Phase
- Phase 3
- 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
- ability to give informed consent
- histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
- node-positive and pathologic stage M0
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients were enrolled 4 to 10 weeks after surgery
- Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits
Who cannot join
- prior chemotherapy or concurrent radiation therapy before esophagectomy
- R1 or R2 resection
- clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
Trial locations and contacts
1 site in 1 country.
Jing Huang contact
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Xi Wang, M.D
Jie He, M.D.
About this study
Official title: Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.
- Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
- No standard postoperative adjuvant chemotherapy has ever been established.
- Conditions
- Esophageal Cancer
- Being tested
- paclitaxel; cisplatin, radiation
- Keywords
- esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel
- 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; cisplatinDrug
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
radiationRadiation
radiation
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | chemotherapy and radiotherapy Receives: Drug: paclitaxel; cisplatin; Radiation: radiation |
| Arm B | Active comparator | radiotherapy Receives: Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year relapse free survival
Measured: 5 years
Secondary outcomes (1)
3 year overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2023 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie He, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461043
- Sponsor's protocol ID
- CH-GI-046
- Status last verified
- Aug 2015
- First submitted
- 30 May 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
- ClinicalTrials.gov ID
- NCT02461043
- Acronym / sponsor ID
- CH-GI-046
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Jun 2015 (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.
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.
- Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
- No standard postoperative adjuvant chemotherapy has ever been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: paclitaxel; cisplatin, Radiation: radiationchemotherapy and radiotherapy |
| Arm B | Active comparator | Radiation: radiationradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ability to give informed consent
- histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
- node-positive and pathologic stage M0
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients were enrolled 4 to 10 weeks after surgery
Key exclusion criteria (3 listed)
- prior chemotherapy or concurrent radiation therapy before esophagectomy
- R1 or R2 resection
- clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
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; cisplatinThe adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles. | Drug | Arm A |
| radiationradiation | Radiation | Arm A, Arm B |
Primary outcome
3 year relapse free survival
Time frame: 5 years
1 secondary outcome
3 year overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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.
Jing Huang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paclitaxel; cisplatin and radiation in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences 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 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: status not confirmed, as of the sponsor's last update on 1 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jing Huang (8610-87788102), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year relapse free survival (time frame: 5 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 1 Sep 2015.