Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age76+
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Paclitaxel plus carboplatin
DrugPaclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
radiotherapy
RadiationDifferent radiotherapy dose in different groups.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: chemoradiotherapyExperimental treatment 2 interventions
Group B: radiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
overall survival difference of definitive radiotherapy and chemoradiotherapy groups
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Time frame
3-yearSecondary outcomes
1
difference of quality of life between different groups
Assess the quality of life through life quality questionnaire.
Time frame
the period of treatment within 7 weeks and follow up time with an average of 3months2
radiation side effects
Record the radiation side effects including acute and late side effects.
Time frame
acute side effects within 3 months, late side effects for 3 months later3
cancer specific survival
The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.
Time frame
3-yearSponsors and contacts
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Fudan University
Lead sponsor
Huadong Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Gansu Cancer Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Fujian Cancer Hospital
Collaborator
Taihe Hospital
Collaborator
Wuxi No. 4 People's Hospital
Collaborator
Ningbo No.2 Hospital
Collaborator
Source ClinicalTrials.gov