Clinical trial NCT02459457: A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage III Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
concurrent chemoradiotherapy
paclitaxel
cisplatin
carboplatin
fluorouracil
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: Wuxi No. 4 People's Hospital
name: Jiangsu Cancer Institute & Hospital
name: The First Affiliated Hospital of Xiamen University
name: Jiangxi Provincial Cancer Hospital
name: Shanxi Province Cancer Hospital
name: Gansu Cancer Hospital
First posted: 2015-06-02
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion criteria

To be eligible for this study, patient must fulfill all of the following criteria:

1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stages II, III or IVa based on the 6th UICC-TNM classification
3. No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
4. Aged 18-75 years
5. Adequate organ functions

   1. White blood cell (WBC) ≥3×109⁄L
   2. Absolute neutrophil counts (ANC) ≥1.5×109⁄L
   3. Hemoglobin (Hb) ≥10g⁄dl
   4. Platelet (Plt) ≥100×109⁄L
   5. Total bilirubin \<1.5 upper limit of normal (ULN)
   6. Aspartate transaminase (AST) ≤2.5 ULN
   7. Alanine aminotransferase (ALT) ≤2.5 ULN
   8. Creatinine ≤1.5 ULN
6. ECOG PS of 0-2
7. Life expectancy ≥3 months
8. Written informed consent

Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.

1. Esophageal perforation or hematemesis
2. 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)
3. Received thoracic, abdominal or craniocerebral surgery within 30 days
4. Enrolled in other clinical trials within 30 days
5. Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
6. Severe psychiatric disease
7. Pregnancy, lactation or unwillingness to adopt contraception
8. Drug addiction
9. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
10. Patients with hearing impairment or sensory-motor neuropathy of WHO grade \> 1
11. History of radiotherapy in the planning area
12. Other ineligible conditions according to researchers

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
measure: progression free survival
timeFrame: 1year, 2 years, 3 years
measure: adverse event
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: +86 18017312534
name: Kuaile Zhao, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.