Esophageal Squamous Cell CarcinomaPhase 2NCT02586753
Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
A Phase 2 study testing Paclitaxel plus Cisplatin with radiotherapy and S1 plus Cisplatin with radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Mianyang Central Hospital.
Trial summary
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Paclitaxel plus Cisplatin with radiotherapy and S1 plus Cisplatin with radiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven squamous cell carcinoma of esophagus .
- Locally advanced esophageal cancer , with no operation indication
- M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
- Subjects haven't been given neither radiotherapy nor chemotherapy before
- Age of 18-70
- PS ≦2
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- Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
- With no difficulty in eating
- Expected lifetime ≧3 months
Who cannot join
- Invasion to surrounding organ ( T4 disease ) .
- Distant metastasis , except M1a disease .
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Women in status of pregnancy
- Patients who have complications exist as following:
- Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
Show all 11Show fewer
- A history of myocardial infarction in the past 6 months
- There is a need for antibiotic treatment of acute bacterial or fungal infection
- Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
- Drug addiction, alcoholism and AIDS disease or long-term virus carriers
- Uncontrollable seizures, or loss of insight because of mental illness
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.
Read the detailed description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Paclitaxel plus Cisplatin with radiotherapy, S1 plus Cisplatin with radiotherapy
- 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.
Paclitaxel plus Cisplatin with radiotherapyOther
we want to compare which regime is better with radiotherapy, PT regime (paclitaxel and cisplatine ) Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
S1 plus Cisplatin with radiotherapyOther
we want to compare which regime is better with radiotherapy,SP regime (Tegafur Gimeracil Oteracil Potassium Capsule and cisplatine).
Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel plus Cisplatin with radiotherapy | Experimental | patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin Receives: Other: Paclitaxel plus Cisplatin with radiotherapy |
| S1 plus Cisplatin with radiotherapy | Experimental | patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin Receives: Other: S1 plus Cisplatin with radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: five years after enrollment
Secondary outcomes (1)
Progression-free survival (PFS)
Measured: five years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mianyang Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Mianyang Central Hospital
- Investigators
- Bo X Du, Doctor, Principal investigator, Mianyang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586753
- Sponsor's protocol ID
- MianyangCH001
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Conroy T, Yataghene Y, Etienne PL, Michel P, Senellart H, Raoul JL, Mineur L, Rives M, Mirabel X, Lamezec B, Rio E, Le Prise E, Peiffert D, Adenis A. Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer. Br J Cancer. 2010 Oct 26;103(9):1349-55. doi: 10.1038/sj.bjc.6605943. Epub 2010 Oct 12.
PubMed 20940718
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Compare Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
- ClinicalTrials.gov ID
- NCT02586753
- Acronym / sponsor ID
- MianyangCH001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Mianyang Central HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 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.
The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.
Detailed description
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel plus Cisplatin with radiotherapy | Experimental | Other: Paclitaxel plus Cisplatin with radiotherapypatients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin |
| S1 plus Cisplatin with radiotherapy | Experimental | Other: S1 plus Cisplatin with radiotherapypatients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically proven squamous cell carcinoma of esophagus .
- Locally advanced esophageal cancer , with no operation indication
- M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
- Subjects haven't been given neither radiotherapy nor chemotherapy before
- Age of 18-70
Key exclusion criteria (11 listed)
- Invasion to surrounding organ ( T4 disease ) .
- Distant metastasis , except M1a disease .
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Women in status of pregnancy
- Patients who have complications exist as following:
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 plus Cisplatin with radiotherapywe want to compare which regime is better with radiotherapy, PT regime (paclitaxel and cisplatine ) Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation. Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. | Other | Paclitaxel plus Cisplatin with radiotherapy |
| S1 plus Cisplatin with radiotherapywe want to compare which regime is better with radiotherapy,SP regime (Tegafur Gimeracil Oteracil Potassium Capsule and cisplatine). Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation. Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. | Other | S1 plus Cisplatin with radiotherapy |
Primary outcome
Overall survival (OS)
Time frame: five years after enrollment
1 secondary outcome
Progression-free survival (PFS)
Time frame: five years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Background: PubMed 20940718Conroy T, Yataghene Y, Etienne PL, Michel P, Senellart H, Raoul JL, Mineur L, Rives M, Mirabel X, Lamezec B, Rio E, Le Prise E, Peiffert D, Adenis A. Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer. Br J Cancer. 2010 Oct 26;103(9):1349-55. doi: 10.1038/sj.bjc.6605943. Epub 2010 Oct 12.
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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.
Bo X Du, Doctor principal investigator
Mianyang Central Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel plus Cisplatin with radiotherapy and S1 plus Cisplatin with radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Mianyang Central Hospital.
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 11 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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao, Doctor (+8618681630773, edna_9999@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: five years after enrollment). 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 NCT02586753, 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 26 Oct 2015; AzTrials last refreshed its copy on 26 Oct 2026.