Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Recruiting now · Not applicable
Conditions studied: Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Survival
In brief
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.
Key facts
- Study ID
- NCT04519905
- Run by
- Fudan University
- People needed
- 320
- Starts
- 2020-01-06
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2021-11-02
Who can join
Age: 76 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Total radiotherapy dose cannot reach 61.2Gy/34Fx
- Esophageal perforation, or hematemesis
- History of radiotherapy or chemotherapy for esophageal cancer
- History of surgery within 28 days before Day 1
- 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)
- Participation in other interventional clinical trials within 30 days
- Pregnant or breast-feeding women or fertile patients
- Drug addiction,
- alcoholism or AIDS
- Uncontrolled seizures or psychiatric disorders
Where it is running
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (enrolling)
- Huadong Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Fudan Universtiy Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.