- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623737
Comparing Paclitaxel/Cisplatin and Cisplatin/5-fluorouracil in Neo-CRT for ESCC
A Randomized Phase II/III Study of Paclitaxel/Cisplatin Versus Cisplatin/5-fluorouracil in Neoadjuvant Chemoradiation Followed by Surgery for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stage 1: Neoadjuvant chemoradiation (CRT):
Stage 2: Evaluation of clinical responses
- Evaluation will be done at 3±1 weeks after completing the last fraction of radiotherapy.
- Evaluation will be performed with panendoscopy, endoscopic ultrasonography (EUS), computed tomography (CT), and positron emission tomography (PET).
Stage 3: Surgery
Patients will receive esophagectomy with two field lymph node dissection unless:
A. Patients become medically unfit for surgery. B. Tumor becomes metastatic or unresectable. C. Patients refuse surgery.
Patients who do not receive surgery will go on a second section of CRT:
A. Radiation: 180cGy/fraction, once daily, 5 days a week, up to a total of 6,300cGy.
B. Arm A:
i. T: Paclitaxel 50 mg/m2, 1h IVF, weekly, week 1 to week 3 during CRT. ii. P: Cisplatin 30 mg/m2, 2 h IVF, weekly following paclitaxel, week 1 to week 3 during CRT.
C. Arm B:
i. P: Cisplatin 75 mg/m2, 2 h IVF, on day 1 of week 1 during CRT. ii. F: 5-FU 1,000 mg/m2, 24 h IVF, on day 1, 2, 3, 4 of week 1 during CRT.
- Patients, who receive surgery with R2 resection or the pathology showing positive margins or extracapsular invasion of regional lymph nodes, will also receive the second section of CRT described in above-mentioned stage 3-2.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Ta-Chen Huang, MD
- Phone Number: +886937817390
- Email: e360215@gmail.com
Study Locations
-
-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Ta-Chen Huang, MD
- Phone Number: +886-2-2312-3456
- Email: e360215@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (7th edition), fulfilling one of the following criteria as determined by endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
A. T3/4a, N0, M0; B. T1-3, N1-3, M0;
- Tumor length longitudinal ≤ 8cm and radial ≤ 5cm.
- The tumor must not extend more than 2cm into the stomach.
- The tumor must not involve cervical esophagus.
- No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
- Age ≥ 20 and ≤ 75 years old.
- Performance status ECOG 0~2.
Adequate bone marrow reserves, defined as:
A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
Adequate liver function reserves, defined as:
A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 2.0 x upper limit of normal (ULN).
- Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml/min (estimated by Cockcroft-Gault formulation)
- Written informed consent.
- Patients must be able to fill in quality of life questionnaires.
Exclusion Criteria:
- Adenocarcinoma.
- Previous thoracic irradiation.
- Previous systemic chemotherapy
- Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
Prior malignancy, except for the following:
A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. a "cured" malignancy more than 5 years prior to enrollment.
- Significant co-morbid disease, which prohibits the conduction of chemotherapy, concurrent chemo- radiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
- Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block.
- Pre-existing motor or sensory neurotoxicity greater than grade 1.
- Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine.
- Weight loss > 15%.
- Dementia or altered mental status that would prohibit the understanding and completion of informed consent and questionnaires.
- Estimated life expectancy less than 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: paclitaxel plus cisplatin
A. T: Paclitaxel 50 mg/m2, 1h IVF, weekly, week 1 to week 5 during CRT.
B. P: Cisplatin 30 mg/m2, 2 h IVF, weekly following paclitaxel, week 1 to week 5 during CRT.
|
Neoadjuvant chemoradiation:
Other Names:
|
Active Comparator: cisplatin plus 5-fluorouracil
A. P: Cisplatin 75 mg/m2, 2 h IVF, on day 1 of week 1 and week 5 during CRT.
B. F: 5-FU 1,000 mg/m2, 24 h IVF, on day 1, 2, 3, 4 of week 1 and week 5 during CRT.
|
Neoadjuvant chemoradiation:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathological complete response
Time Frame: 2 years
|
No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 4 years
|
Time from enrollment to death
|
4 years
|
disease free survival
Time Frame: 4 years
|
From the day of surgery with R0 resection to recurrence or death of any reasons
|
4 years
|
clinical response
Time Frame: 2 years
|
The clinical response evaluation for the effect of neoadjuvant CRT will be done around 3±1 weeks after completing CRT. Evaluation will be performed with panendoscopy, EUS, CT, and PET. Clinical responses assessment will include:
|
2 years
|
operation rate
Time Frame: 2 years
|
The ratio of the number of patients who receive surgery over the number of patients enrolled
|
2 years
|
R0 resection rate
Time Frame: 2 years
|
The ratio of the number of patients with surgical R0 resection over the number of patients who receive surgery
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2 years
|
tumor regression grade
Time Frame: 2 years
|
A 4-tiered tumor regression grading (TRG) system will be used according to the extent of residual carcinoma in the whole tumor area of the esophageal specimen. TRG 1: no residual carcinoma. TRG 2: 1%- 10% residual carcinoma. TRG 3: 11%- 50% residual carcinoma. TRG 4: >50% residual carcinoma |
2 years
|
The total score of participants of both arms will be analyzed and compared.
Time Frame: 2 years
|
By World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Taiwan version (2005), quality of life will be assessed at enrollment, at the end of neoadjuvant CRT, and 3 months after surgery. There are 28 subscales in the questionnaire. Each subscale has 5 scores from 1 (the worst) to 5 (the best). The scores of each subscale are summed to be a total score. |
2 years
|
Number of participants with treatment-related adverse events as assessed by the NCI Common Toxicity Criteria (CTC)
Time Frame: 2 years
|
By the NCI Common Toxicity Criteria (CTC), version 4.0., number of participants with treatment-related adverse events, all grades and grade 3/4, will be assessed.
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- 201606102MIPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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