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Esophagus CancerPhase 3NCT03002064

Docetaxol Plus Cisplatin Versus 5-Fu Plus Cisplatin as 1st-line Chemotherapy in Advanced ESCC Patients

A Phase 3 study testing Docetaxel, Fluorouracil and Cisplatin in people with Esophagus Cancer and Chemotherapy Effects, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal squamous carcinoma patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophagus Cancer, Chemotherapy Effects
What is being tested?
Docetaxel, Fluorouracil and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
1 siteChina
Study dates
Dec 2016to Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment. Patients were allowed to have palliative radiotherapy 3 months before the enrollment and the target lesions should not be within the radiotherapy region. The last date of adjuvant therapy should be over 6 months before the enrollment.
  • With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • With an expected life expectancy of ≥ 3 months.
  • With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Without serious system dysfunction and could tolerate chemotherapy.
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  • Patients must have normal bone marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×10^9/L，a neutrophil count of ≥2.0×10^9/L, , a platelet count of ≥100×10^9/L.
  • Patients must have normal liver and renal function with a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
  • Patients must have normal electrocardiogram results and no history of congestive heart failure.
  • Women of childbearing age should voluntarily take contraceptive measures. Without drug addition
  • Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.

Who cannot join

  • Allergic to known drug
  • Patients who have received prior treatment including chemotherapy, radiotherapy and surgery for the advanced or metastatic diseases.
  • Receive docetaxel within 6 months as adjuvant or neoadjuvant chemotherapy.
  • Brain metastasis.
  • Without measurable or evaluable disease.
  • With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
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  • With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
  • With neurological or psychiatric abnormalities that affect cognitive.
  • Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)

Trial locations and contacts

1 site in 1 country.

Rui-Hua Xu, MD, PhD contact

86-020-87343333

xurh@sysucc.org.cn

Miao-Zhen Qiu, MD, PhD contact

86-020-87342490

qiumzh@sysucc.org.cn

China1 site, 1 recruiting

  • Cancer center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Rui-Hua Xu, MD, PhD, 86-020-87343333, xurh@sysucc.org.cn

    Miao-Zhen Qiu, MD, PhD, 86-020-87342490, qiumzh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin as First-line Treatment for Metastatic Esophageal Squamous Patients: a Prospective Multicenter, Randomized Controlled Clinical Study

This is a phase III clinical trial to compare the efficacy of docetaxel plus cisplatin versus 5-Fu plus cisplatin in the first line chemotherapy for advanced or metastatic esophageal squamous carcinoma patients.

Read the detailed description

Esophageal cancer is the 6th most common cause of cancer deaths worldwide and it is an endemic in many parts of the world, particularly in the developing countries, including China. Histologically, esophageal cancer can be classified as adenocarcinoma and esophageal squamous cell. carcinoma (ESCC) which is the most common histology in Asia. For locally advanced or metastatic ESCC patients, chemotherapy can improve overall survival (OS) and progression free survival (PFS). There is no standard first-line chemotherapy for ESCC patients. Cisplatin (DDP) plus fluorouracil is the most common used combination with a response rate of 25-35%. Previous studies showed that the combination of paclitaxel with cisplatin had good tolerance and efficacy to esophageal carcinoma. This is a prospective randomized control phase III clinical trial to compare the efficacy and safety between docetaxel/cisplatin and 5-Fu/cisplatin as the 1st line treatment in advanced or metastatic esophageal carcinoma patients.

Sample size:

This is a non-inferior study. The planned sample size was 358 patients, allowing for a 10% dropout rate and assuming the median progression free survival was 5.5 months in the experimental group and 4 months in the control group with a hazard ratio of 0.727, α=0.05, β=0.2. The planned enrolled time was 36 months and 12 months of follow up. The ratio between control and experimental group is 1:1.

Keywords
Esophagus squamous carcinoma, First-line chemotherapy, Docetaxel, Cisplatin, 5-fluorouracil
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Docetaxol

    60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.

  • FluorouracilDrug

    Also called 5-Fu

    5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles

  • CisplatinDrug

    Also called DDP

    Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles

Study groups in NCT03002064
Study groupRoleWhat they receive
DP groupExperimentalDocetaxel plus cisplatin. Docetaxel: 60mg per square metre on day 1 and Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
Receives: Drug: Docetaxel; Drug: Cisplatin
PF groupActive comparatorCisplatin plus 5-fluorouracil. Cisplatin: 60mg per square metre on day 1 and 5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles.
Receives: Drug: Fluorouracil; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first

    Measured: 36 months

Secondary outcomes (4)

  1. Overall survival

    From the date of randomization until the date of death from any cause.

    Measured: 36 months

  2. Response rate

    Including complete response and partial response

    Measured: 36 months

  3. Grade 3 and 4 toxicities

    According to the CTCAE

    Measured: 36 months

  4. Quality of life--Score of the questionnaire

    EORTC QLQ-C30 and QLQ-OES18 questionnaire.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
358 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002064
Sponsor's protocol ID
SYSUCC-ESO-01
Status last verified
Dec 2016
First submitted
16 Dec 2016
Last updated
26 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Fluorouracil and Cisplatin in people with Esophagus Cancer and Chemotherapy Effects, run by Sun Yat-sen University 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 11 inclusion and 9 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 Dec 2016. 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 Rui-Hua Xu, MD, PhD (86-020-87343333, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 36 months). 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 NCT03002064.

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 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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