Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600831
• Other study ID #: huaianzhuweiguo
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 20, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Huai'an First People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: December 31, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. biopsy-confirmed esophageal squamous cell carcinoma

2. age = 70 years old,

3. Karnofsky performance status = 70,

4. R0 esophagectomy according to the pathological examination of the resected specimens,

5. postoperative stage ?-?a according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma

6. 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; (9).adequate pulmonary function (FEV1>0.8 L;.

7. no previous treatment or severe complications

8. Written informed consent

Exclusion Criteria:

1. previous treatment with chemotherapy or radiotherapy

2. greater than 3 months after surgery

3. complete esophageal obstruction after surgery, esophageal perforation;

4. other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;

5. pregnant or breast-feeding women;

6. patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease;

7. drug addiction, Alcoholism or AIDS;

8. uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;

9. with clear chemotherapy drug allergy

10. participation in other interventional clinical trials within 30 days;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Docetaxel plus cisplatin
cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks

Radiation:
• radiotherapy
radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)

Locations

Country	Name	City	State
China	Chinese Peiple's Liberation Army No.82 Hospital	Huai'an	Jiangsu
China	Huai'an second peiple's Hospital	Huai'an	Jiangsu
China	Lianshui County Peoples Hospital	Huai'an	Jiangsu
China	xuyi peiple's Hospital	Xu Yi	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
Huai'an First People's Hospital	Chinese People's Liberation Army No. 82 Hospital, lian shui county People's Hospital, The Second People's Hospital of Huai'an, xuyi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause?	From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Secondary	Overall survival (OS)	From the date of randomization until the date of death	From date of randomization to death from any cause, assessed up to 3 years
Secondary	treatment-related toxicities	Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0	From the date of randomization until six months after treatment completion
Secondary	Quality of life(QOL)	Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months.	1 year