NCT03600831CompletedPhase 2/3
Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 9 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 434 (actual)
- First submitted
- 3 Jul 2018
- Start date
- 20 Aug 2018
- Primary completion date
- 30 May 2022
- Lead sponsor
- Huai'an First People's Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03600831
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 434
- From 20 Aug 2018 to the primary completion date, 30 May 2022
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous treatment with chemotherapy or radiotherapy
- greater than 3 months after surgery
- patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease;
- drug addiction, Alcoholism or AIDS;
Other illness
- 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;
- uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- with clear chemotherapy drug allergy
Other
- pregnant or breast-feeding women;
- participation in other interventional clinical trials within 30 days;
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Peiple's Liberation Army No.82 Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| Huai'an second peiple's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| Lianshui County Peoples Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| xuyi peiple's Hospital Coordinator of this site? Confirm its status | Xucheng | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.