Stage III Esophageal Squamous Cell CarcinomaPhase 3DCECRTNCT02603159
Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy
A Phase 3 study testing Capecitabine(Aibin) and radiotherapy in people with Stage III Esophageal Squamous Cell Carcinoma and Stage II Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial summary
Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma
- What is being tested?
- Capecitabine(Aibin) and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2019
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 45-75years old
- Histologically proven squamous cell carcinoma of the esophagus
- the tumor was in T2-4N0-2M0
- The patients have not received the surgery or chemo-radiotherapy.
- Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
- ALT、AST≤2.5*N,Cr≤1.5*N.
- performance status score 0-2
Who cannot join
- pregnant, lactating women
- Oxaliplatin or fluorouracil Allergy or metabolic disorders
- Radiotherapy contraindications
- History of organ transplantation
- Brain metastasis
- The peripheral nervous system disorders
Show all 10Show fewer
- Severe infection
- Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
- Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
- Other malignant tumor in recent 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
shegan gao, doctor, 0379 64811906, gsg112258@163.com
tanyou shan, master, 0379 64815350, shantanyou@163.com
About this study
Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer.
The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.
Read the detailed description
We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.
- Being tested
- Capecitabine(Aibin), radiotherapy
- Keywords
- Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine(Aibin)Drug
Also called Aibin
Capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total
radiotherapyRadiation
Also called radiation therapy
Concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine-5 weeks-radiotherapy | Experimental | Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w. Receives: Drug: Capecitabine(Aibin); Radiation: radiotherapy |
| Capecitabine-10 weeks-radiotherapy | Active comparator | Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w. Receives: Drug: Capecitabine(Aibin); Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival, OS
Measured: 2 years
Secondary outcomes (5)
progression-free survival
Measured: 2 years
overall remission rate, ORR
Measured: 16 weeks
serious adverse event
Measured: 16 weeks
quality of life, Qol
Measured: 16 weeks
pathologic complete response rate
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
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 Stage III Esophageal Squamous Cell CarcinomaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shegan Gao, Doctor, Study chair, The First Affiliated Hospital of Henan University of Science and TechnologyTanyou Shan, Master, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyXiaoshan Feng, Doctor, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyJiachun Sun, Doctor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXinshuai Wang, Doctor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyGuoqiang Kong, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXiaozhi Yuan, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyRuinuo Jia, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603159
- Sponsor's protocol ID
- Capecitabine and esophageal
- Acronym
- DCECRT
- Status last verified
- Oct 2015
- First submitted
- 9 Nov 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.
PubMed 20888705
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02603159
- Acronym / sponsor ID
- DCECRT / Capecitabine and esophageal
- Keywords
- Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Nov 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.
Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer.
The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.
Detailed description
We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine-5 weeks-radiotherapy | Experimental | Drug: Capecitabine(Aibin), Radiation: radiotherapyCapecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w. |
| Capecitabine-10 weeks-radiotherapy | Active comparator | Drug: Capecitabine(Aibin), Radiation: radiotherapyCapecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 45-75years old
- Histologically proven squamous cell carcinoma of the esophagus
- the tumor was in T2-4N0-2M0
- The patients have not received the surgery or chemo-radiotherapy.
- Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
Key exclusion criteria (10 listed)
- pregnant, lactating women
- Oxaliplatin or fluorouracil Allergy or metabolic disorders
- Radiotherapy contraindications
- History of organ transplantation
- Brain metastasis
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 |
|---|---|---|
| Capecitabine(Aibin)Also: AibinCapecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total | Drug | Capecitabine-10 weeks-radiotherapy, Capecitabine-5 weeks-radiotherapy |
| radiotherapyAlso: radiation therapyConcurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity | Radiation | Capecitabine-10 weeks-radiotherapy, Capecitabine-5 weeks-radiotherapy |
Primary outcome
overall survival, OS
Time frame: 2 years
5 secondary outcomes
progression-free survival
Time frame: 2 years
overall remission rate, ORR
Time frame: 16 weeks
serious adverse event
Time frame: 16 weeks
quality of life, Qol
Time frame: 16 weeks
pathologic complete response rate
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Background: PubMed 20888705Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.
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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.
Shegan Gao, Doctor study chair
The First Affiliated Hospital of Henan University of Science and Technology
Tanyou Shan, Master study director
The First Affiliated Hospital of Henan University of Science and Technology
Xiaoshan Feng, Doctor study director
The First Affiliated Hospital of Henan University of Science and Technology
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 Capecitabine(Aibin) and radiotherapy in people with Stage III Esophageal Squamous Cell Carcinoma and Stage II Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology 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 10 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 11 Nov 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 Shegan Gao, Doctor (18638859977, gsg112258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival, OS (time frame: 2 years). 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 NCT02603159, 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 11 Nov 2015.