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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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concurrent chemoradiotherapy group

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

Group Type EXPERIMENTAL

Docetaxel plus cisplatin

Intervention Type DRUG

cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks

radiotherapy

Intervention Type RADIATION

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

radiotherapy group

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

Group Type ACTIVE_COMPARATOR

radiotherapy

Intervention Type RADIATION

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

Interventions

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Docetaxel plus cisplatin

cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks

Intervention Type DRUG

radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No