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Stage III Esophageal Squamous Cell CarcinomaPhase 3NCT02459457

A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

A Phase 3 study testing Paclitaxel and Cisplatin, Paclitaxel and Fluorouracil and Paclitaxel and Carboplatin in people with Stage III Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Paclitaxel and Cisplatin, Paclitaxel and Fluorouracil and Paclitaxel and Carboplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
1 siteChina
Study dates
1 Jul 2015to Feb 2022
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

  • To be eligible for this study, patient must fulfill all of the following criteria:
  • Histologically confirmed esophageal squamous cell carcinoma
  • Clinical stages II, III or IVa based on the 6th UICC-TNM classification
  • No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
  • Aged 18-75 years
  • Adequate organ functions
Show all 30Show fewer
  • White blood cell (WBC) ≥3×109⁄L
  • Absolute neutrophil counts (ANC) ≥1.5×109⁄L
  • Hemoglobin (Hb) ≥10g⁄dl
  • Platelet (Plt) ≥100×109⁄L
  • Total bilirubin <1.5 upper limit of normal (ULN)
  • Aspartate transaminase (AST) ≤2.5 ULN
  • Alanine aminotransferase (ALT) ≤2.5 ULN
  • Creatinine ≤1.5 ULN
  • ECOG PS of 0-2
  • Life expectancy ≥3 months
  • Written informed consent
  • Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.
  • Esophageal perforation or hematemesis
  • Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
  • Received thoracic, abdominal or craniocerebral surgery within 30 days
  • Enrolled in other clinical trials within 30 days
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
  • Severe psychiatric disease
  • Pregnancy, lactation or unwillingness to adopt contraception
  • Drug addiction
  • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
  • Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1
  • History of radiotherapy in the planning area
  • Other ineligible conditions according to researchers

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

Being tested
Paclitaxel and Cisplatin, Paclitaxel and Fluorouracil, Paclitaxel and Carboplatin, Radiotherapy
Keywords
esophageal squamous cell carcinoma, concurrent chemoradiotherapy, paclitaxel, cisplatin, carboplatin, fluorouracil
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 and CisplatinDrug

    Also called TP

    patients get Paclitaxel and Cisplatin according to protocol

  • Paclitaxel and FluorouracilDrug

    Also called TF

    patients get Paclitaxel and Fluorouracil according to protocol

  • Paclitaxel and CarboplatinDrug

    Also called TC

    patients get Paclitaxel and Carboplatin according to protocol

  • RadiotherapyRadiation

    1.8Gy/d, d1-5/week, 34Fx

Study groups in NCT02459457
Study groupRoleWhat they receive
Paclitaxel and Cisplatin (TP)Active comparatorPatients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w*4
Receives: Drug: Paclitaxel and Cisplatin; Radiation: Radiotherapy
Paclitaxel and Fluorouracil (TF)Active comparatorPatients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w*2
Receives: Drug: Paclitaxel and Fluorouracil; Radiation: Radiotherapy
Paclitaxel and Carboplatin（TC）Active comparatorPatients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w*2
Receives: Drug: Paclitaxel and Carboplatin; Radiation: Radiotherapy

What is being measured

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

  1. overall survival

    Measured: 3 years

Secondary outcomes (2)

  1. progression free survival

    Measured: 1year, 2 years, 3 years

  2. adverse event

    Measured: 3 years

Timeline

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

  1. First posted2 Jun 2015 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion1 Jul 2020
  4. Study completionFeb 2022

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
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459457
Sponsor's protocol ID
ESO-Shanghai 2
Status last verified
Feb 2022
First submitted
23 May 2015
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Ai D, Ye J, Wei S, Li Y, Luo H, Cao J, Zhu Z, Zhao W, Lin Q, Yang H, Zheng X, Zhou J, Huang G, Li L, Li J, Zhang Z, Zhou G, Gu D, Du M, Mo M, Jia H, Zhang Z, Zhao K. Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220120. doi: 10.1001/jamanetworkopen.2022.0120.

    PubMed 35188552

  • Ai D, Chen Y, Liu Q, Zhang J, Deng J, Zhu H, Ren W, Zheng X, Li Y, Wei S, Ye J, Zhou J, Lin Q, Luo H, Cao J, Li J, Huang G, Wu K, Fan M, Yang H, Zhu Z, Zhao W, Li L, Fan J, Badakhshi H, Zhao K. Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2). BMJ Open. 2018 Oct 21;8(10):e020785. doi: 10.1136/bmjopen-2017-020785.

    PubMed 30344165

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel and Cisplatin, Paclitaxel and Fluorouracil and Paclitaxel and Carboplatin in people with Stage III Esophageal Squamous Cell Carcinoma, run by Fudan 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 30 inclusion and 0 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: finished, as of the sponsor's last update on 9 Feb 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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?

On the ClinicalTrials.gov record for NCT02459457, which also lists 2 linked publications.

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 9 Feb 2022.

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