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

Conditions

Stage III Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinoma, concurrent chemoradiotherapy, paclitaxel, cisplatin, carboplatin, fluorouracil

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.

Dashan Ai, Jinjun Ye, Shihong Wei, Yunhai Li, Hui Luo et al. (23 authors)

JAMA Network Open2022-02-2168 citations

10.1001/jamanetworkopen.2022.0120

Final results of a phase III randomized trial of comparison of three paclitaxel-based regimens concurrent with radiotherapy for patients with local advanced esophageal squamous cell carcinoma.

Dashan Ai, Jinjun Ye, Yun Chen, Qi Liu, Xiangpeng Zheng et al. (20 authors)

Journal of Clinical Oncology2020-05-202 citations

10.1200/jco.2020.38.15_suppl.4564

Safety results of a phase III randomized trial of comparison of three paclitaxel-based regimens concurrent with radiotherapy for patients with local advanced esophageal squamous cell carcinoma (ESO-Shanghai 2).

Dashan Ai, Yun Chen, Qi Liu, Xiangpeng Zheng, Yunhai Li et al. (20 authors)

Journal of Clinical Oncology2019-05-20

10.1200/jco.2019.37.15_suppl.4055

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)

Dashan Ai, Yun Chen, Qi Liu, Junhua Zhang, Jiaying Deng et al. (26 authors)

BMJ Open2018-10-017 citations

10.1136/bmjopen-2017-020785

A phase II trial of concurrent chemoradiotherapy with weekly paclitaxel and carboplatin in advanced oesophageal carcinoma.

Xia Y, Li YH, Chen Y, Liu Q, Zhang JH, Deng JY, Ai TS, Zhu HT, Badakhshi H, Zhao KL.

2018-02-1212 citations

10.1007/s10147-018-1240-4

A phase II study of concurrent chemoradiotherapy combined with a weekly paclitaxel and 5-fluorouracil regimen to treat patients with advanced oesophageal carcinoma

Yi Xia, Yunhai Li, Yun Chen, Junhua Zhang, Qi Liu et al. (11 authors)

Radiation Oncology2017-03-077 citations

10.1186/s13014-017-0785-0

Interventions

DRUGPaclitaxel and Cisplatin

patients get Paclitaxel and Cisplatin according to protocol

DRUGPaclitaxel and Fluorouracil

patients get Paclitaxel and Fluorouracil according to protocol

DRUGPaclitaxel and Carboplatin

patients get Paclitaxel and Carboplatin according to protocol

RADIATIONRadiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
overall survival	3 years

Secondary

Measure	Time frame
progression free survival	1year, 2 years, 3 years
adverse event	3 years

Countries

China

Outcome results

None listed