Esophageal Cancer Stage IIBPhase 3NCT03366883
Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC
A Phase 3 study testing Paclitaxel, Cisplatin Plus 5-FU (TCF) and radiochemotherapy in people with Esophageal Cancer Stage IIB and Esophageal Cancer Stage III, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Esophageal Cancer Stage IIB, Esophageal Cancer Stage III
- What is being tested?
- Paclitaxel, Cisplatin Plus 5-FU (TCF) and radiochemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 31 Dec 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven squamous cell carcinoma.
- All lesions are located in the thoracic esophagus.
- Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
- 20-75 years old.
- ECOG performance status of 0 or 1.
- Measurable lesions not required.
Show all 10Show fewer
- No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
- No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
- Adequate organ function.
- Written informed consent.
Who cannot join
- Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
- Active infection requiring systemic therapy
- Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
- Pregnant or lactating women or women of childbearing potential.
- Patients requiring systemic steroid medication.
- Iodine hypersensitivity.
Show all 12Show fewer
- Psychiatric disease.
- Hypersensitivity for CremophorEL.
- Poorly controlled diabetes.
- Severe emphysema or pulmonary fibrosis.
- Poorly controlled hypertension.
- Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
TianjinCIH
Tianjin, Tianjin Municipality, 300060
Yi Ba, MD.PHD, +8613820741351, Bayi@tjmuch.com
Yi Ba, MD.PHD, +8613820741351, bmmhead1982@126.com
About this study
Official title: A Phase III Trial Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy With Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer
This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.
- Being tested
- Paclitaxel, Cisplatin Plus 5-FU (TCF), radiochemotherapy
- Keywords
- preoperative chemotherapy, preoperative chemoradiotherapy, clinical trial, phase III, Esophageal squamous cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel, Cisplatin Plus 5-FU (TCF)Combination product
preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks)
radiochemotherapyRadiation
preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week)
| Study group | Role | What they receive |
|---|---|---|
| "Paclitaxel, Cisplatin Plus 5-FU (TCF) | Experimental | preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks Receives: Combination Product: Paclitaxel, Cisplatin Plus 5-FU (TCF) |
| Preoperative radiochemotherapy | Experimental | preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week Receives: Radiation: radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 3 years
Secondary outcomes (4)
Disease Free Survival
Measured: 3years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through study completion, an average of 1 year
Objective Response Rate
Measured: up to 24 weeks
Rate of R0 resection
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion4 Feb 2018 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Cancer Stage IIBStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Chest Hospital, Henan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366883
- Sponsor's protocol ID
- TianjinCIH20171114
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy With Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer
- ClinicalTrials.gov ID
- NCT03366883
- Acronym / sponsor ID
- TianjinCIH20171114
- Keywords
- preoperative chemotherapy, preoperative chemoradiotherapy, clinical trial, phase III, Esophageal squamous cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Henan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Anhui Medical University
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 4 Feb 2018 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Dec 2017 (actual)
- 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 Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Paclitaxel, Cisplatin Plus 5-FU (TCF) | Experimental | Combination Product: Paclitaxel, Cisplatin Plus 5-FU (TCF)preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks |
| Preoperative radiochemotherapy | Experimental | Radiation: radiochemotherapypreoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven squamous cell carcinoma.
- All lesions are located in the thoracic esophagus.
- Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
- 20-75 years old.
- ECOG performance status of 0 or 1.
Key exclusion criteria (12 listed)
- Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
- Active infection requiring systemic therapy
- Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
- Pregnant or lactating women or women of childbearing potential.
- Patients requiring systemic steroid medication.
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, Cisplatin Plus 5-FU (TCF)preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks) | Combination product | "Paclitaxel, Cisplatin Plus 5-FU (TCF) |
| radiochemotherapypreoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week) | Radiation | Preoperative radiochemotherapy |
Primary outcome
Overall Survival
Time frame: 3 years
4 secondary outcomes
Disease Free Survival
Time frame: 3years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion, an average of 1 year
Objective Response Rate
Time frame: up to 24 weeks
Rate of R0 resection
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer Stage IIB
RecruitingPhase 1
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
Cervical Esophagus Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Active, not recruitingPhase 2
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial
Esophageal Cancer
Recruiting
Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers
Esophageal Carcinoma, Lung Non-Small Cell Carcinoma
RecruitingPhase 2
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
Advanced Esophageal Squamous Cell Carcinoma, Advanced Renal Cell Carcinoma
Active, not recruitingPhase 1
Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery
Advanced Esophageal Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
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.
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 Paclitaxel, Cisplatin Plus 5-FU (TCF) and radiochemotherapy in people with Esophageal Cancer Stage IIB and Esophageal Cancer Stage III, run by Tianjin Medical University Cancer Institute and 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 10 inclusion and 12 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 9 Jan 2018. 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 Yi Ba, MD,PHD (+8618622221230, bayi@tjmuch.com), or a site near the patient. 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?
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 Jan 2018.