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

Huai'an First People's Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Docetaxel plus cisplatin; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03600831

huaianzhuweiguo

Details and patient eligibility

About

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.

Enrollment: 434 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 Ⅱ-Ⅳa 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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434 participants in 2 patient groups

concurrent chemoradiotherapy group

Experimental group

Description:

All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).

Treatment:

Drug: Docetaxel plus cisplatin

Radiation: radiotherapy

radiotherapy group

Active Comparator group

Description:

All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).

Treatment:

Radiation: radiotherapy