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

NCT03600831 | Completed Phase 2

• 1 other identifier: huaianzhuweiguo
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 4

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal neoplasma; adjuvant therapy; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  From date of randomization to death from any cause, assessed up to 3 years

• treatment-related toxicities

  From the date of randomization until six months after treatment completion

• Quality of life(QOL)

  1 year

Study Arms (2)

concurrent chemoradiotherapy group

EXPERIMENTAL

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

Drug: Docetaxel plus cisplatin; Radiation: radiotherapy

radiotherapy group

ACTIVE COMPARATOR

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

Radiation: radiotherapy

Interventions

Docetaxel plus cisplatin DRUG

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

concurrent chemoradiotherapy group

radiotherapy RADIATION

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

concurrent chemoradiotherapy group; radiotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsy-confirmed esophageal squamous cell carcinoma
• age ≤ 70 years old,
• Karnofsky performance status ≥ 70,
• R0 esophagectomy according to the pathological examination of the resected specimens,
• postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
• 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;.
• no previous treatment or severe complications
• Written informed consent

You may not qualify if:

• previous treatment with chemotherapy or radiotherapy
• greater than 3 months after surgery
• complete esophageal obstruction after surgery, esophageal perforation;
• other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
• pregnant or breast-feeding women；
• patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease；
• drug addiction, Alcoholism or AIDS;
• uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
• with clear chemotherapy drug allergy
• participation in other interventional clinical trials within 30 days;

Sponsors & Collaborators

• Huai'an First People's Hospital: lead
• The Second People's Hospital of Huai'an: collaborator
• lian shui county People's Hospital: collaborator
• xuyi People's Hospital: collaborator
• Chinese People's Liberation Army No. 82 Hospital: collaborator

Study Sites (4)

Chinese Peiple's Liberation Army No.82 Hospital

Huai'an, Jiangsu, 223300, China

Location

Huai'an second peiple's Hospital

Huai'an, Jiangsu, 223300, China

Location

Lianshui County Peoples Hospital

Huai'an, Jiangsu, 223300, China

Location

xuyi peiple's Hospital

Xucheng, Jiangsu, 211700, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Docetaxel; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: August 20, 2018
• Primary Completion: May 30, 2022
• Study Completion: December 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

CN (4)