Clinical trial NCT03600831: Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
Official title: A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal neoplasma
adjuvant therapy
chemotherapy
radiotherapy
Lead sponsor: Huai'an First People's Hospital
Sponsor class: OTHER
Collaborators: name: The Second People's Hospital of Huai'an
name: lian shui county People's Hospital
name: xuyi People's Hospital
name: Chinese People's Liberation Army No. 82 Hospital
First posted: 2018-07-26
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 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 outcomes:
measure: Overall survival (OS)
timeFrame: From date of randomization to death from any cause, assessed up to 3 years
measure: treatment-related toxicities
timeFrame: From the date of randomization until six months after treatment completion
measure: Quality of life(QOL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Chinese Peiple's Liberation Army No.82 Hospital
state: Jiangsu
city: Huai'an
country: China
facility: Huai'an second peiple's Hospital
state: Jiangsu
city: Huai'an
country: China
facility: Lianshui County Peoples Hospital
state: Jiangsu
city: Xu Yi
country: China
facility: xuyi peiple's Hospital
state: Jiangsu
Study officials:
References: