NCT04519905Recruiting
Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Source: ClinicalTrials.gov · Last updated 2 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 12 Aug 2020
- Start date
- 6 Jan 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04519905
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 6 Jan 2020 to the primary completion date, 31 Dec 2024
- 3 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
- Total radiotherapy dose cannot reach 61.2Gy/34Fx
- History of surgery within 28 days before Day 1
- Drug addiction,
Other illness
- Esophageal perforation, or hematemesis
- History of radiotherapy or chemotherapy for esophageal cancer
- History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
- Uncontrolled seizures or psychiatric disorders
Other
- Participation in other interventional clinical trials within 30 days
- Pregnant or breast-feeding women or fertile patients
- alcoholism or AIDS
Who the study is looking for
- Indicates no limit on eligibility based on the sex of participants
- The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
- Esophageal squamous cell carcinoma confirmed by pathology
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
- Use of an effective contraceptive for adults to prevent pregnancy
- No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
- No immunodeficiency
- ECOG 0-1.
- Life expectancy of more than 3 months.
Age in the registry: 76 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Huadong Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fudan Universtiy Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.