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

Stage III Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459457
• Other study ID #: ESO-Shanghai 2
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2015
• Est. completion date: February 2022

Study information

• Verified date: February 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: February 2022
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Stage III Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Paclitaxel and Cisplatin
patients get Paclitaxel and Cisplatin according to protocol
• Paclitaxel and Fluorouracil
patients get Paclitaxel and Fluorouracil according to protocol
• Paclitaxel and Carboplatin
patients get Paclitaxel and Carboplatin according to protocol

Radiation:
• Radiotherapy
1.8Gy/d, d1-5/week, 34Fx

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Fudan University	Gansu Cancer Hospital, Huadong Hospital, Jiangsu Cancer Institute & Hospital, Jiangxi Provincial Cancer Hospital, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Xiamen University, Wuxi No. 4 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years
Secondary	progression free survival		1year, 2 years, 3 years
Secondary	adverse event		3 years