Esophageal CancerPhase 3NCT02570893
A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma
A Phase 3 study testing Adjuvant radiotherapy and Paclitaxel and carboplatin in people with Esophageal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma. 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?
- Adjuvant radiotherapy and Paclitaxel and carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Oct 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
- Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
- The expectation of life is more than 6 months;
- Age: 18~70 years old;
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
- ECOG (Eastern Cooperative Oncology Group) : 0-1;
- Able to understand this study and have signed informed consent.
Who cannot join
- Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
- Known or suspected of allergy to paclitaxel or carboplatin;
- Female in pregnancy or lactating;
- With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
- Patients with peripheral neuropathy(CTC grade≥2);
- With other malignant tumors before the recruitment.
- The researchers consider that the patient is not appropriate to enroll the study;
- The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Weimin Mao, MD., +86-571-88122032, maowmzj1218@163.com
Yaping Xu, MD., +86-571-88122082, xuyaping1207@gmail.com
About this study
Official title: A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
Read the detailed description
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only
- Conditions
- Esophageal Cancer
- Being tested
- Adjuvant radiotherapy, Paclitaxel and carboplatin
- Keywords
- Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant radiotherapyRadiation
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
Adjuvant radiotherapyRadiation
adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
Paclitaxel and carboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| adjuvant chemoradiotherapy | Experimental | Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy. Receives: Radiation: Adjuvant radiotherapy; Drug: Paclitaxel and carboplatin |
| adjuvant radiotherapy | Experimental | Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy. Receives: Radiation: Adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall survival
To evaluate the 3 years overall survival of two groups.
Measured: 3 years
Secondary outcomes (3)
Disease-free survival
To evaluate the 3 years disease-free survival of two groups.
Measured: 3 years
Adverse Events
Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0
Measured: 1 year
Scores of Quality of life
Assess the quality of life based on FACT-E
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2020 (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 Zhejiang Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weimin Mao, MD., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570893
- Sponsor's protocol ID
- ZTOG-1401
- Status last verified
- Oct 2015
- First submitted
- 3 Oct 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02570893
- Acronym / sponsor ID
- ZTOG-1401
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 7 Oct 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.
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
Detailed description
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adjuvant chemoradiotherapy | Experimental | Radiation: Adjuvant radiotherapy, Drug: Paclitaxel and carboplatinAdjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy. |
| adjuvant radiotherapy | Experimental | Radiation: Adjuvant radiotherapyAdjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
- Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
- The expectation of life is more than 6 months;
- Age: 18~70 years old;
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
Key exclusion criteria (8 listed)
- Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
- Known or suspected of allergy to paclitaxel or carboplatin;
- Female in pregnancy or lactating;
- With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
- Patients with peripheral neuropathy(CTC grade≥2);
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 |
|---|---|---|
| Adjuvant radiotherapyAdjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy. | Radiation | adjuvant chemoradiotherapy |
| Adjuvant radiotherapyadjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy. | Radiation | adjuvant radiotherapy |
| Paclitaxel and carboplatin | Drug | adjuvant chemoradiotherapy |
Primary outcome
The overall survival
Time frame: 3 years
To evaluate the 3 years overall survival of two groups.
3 secondary outcomes
Disease-free survival
Time frame: 3 years
Adverse Events
Time frame: 1 year
Scores of Quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 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.
Weimin Mao, MD. principal investigator
Zhejiang Cancer Hospital
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 Adjuvant radiotherapy and Paclitaxel and carboplatin in people with Esophageal Cancer, run by Zhejiang Cancer 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 7 inclusion and 8 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 Oct 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 Weimin Mao, MD. (+86-571-88122032, maowmzj1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall 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 Oct 2015.