NCT04764227Active, not recruitingPhase 2
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
Source: ClinicalTrials.gov · Last updated 3 Aug 2023
Brief summary (registry, in English)
The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 19 Feb 2021
- Start date
- 30 May 2020
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04764227
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 70
- From 30 May 2020 to the primary completion date, 30 Mar 2024
- 1 site 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
- Drug addiction, Alcoholism or AIDS;
Other illness
- Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
- 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;
Other
- Participation in other interventional clinical trials within 30 days;
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- Unsuitable to be enrolled in the trial in the opinion of the investigators.
Who the study is looking for
- Joined the study voluntarily and signed informed consent form;
- Age 18-75;
- ECOG 0-2;
- Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
- The operative incision healed well;
- T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
- No radiotherapy, chemotherapy or other treatments pre (post) surgery;
- PS ECOG 0-2;
- Life expectancy of more than 3 months;
- Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
- Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN;
- Renal function: creatinine \< 1.5 x ULN
- No immuno-deficiency;
- Use of an effective contraceptive for adults to prevent pregnancy.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.