Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Not Applicable

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Survival
• Interventions: Drug: Paclitaxel plus carboplatin; Radiation: radiotherapy

• Registration Number: NCT04519905
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.

Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.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. The life quality questionnaire included QlQ-C30 and OES-18.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-31
• Last Update Posted: 2021-11-02
• Primary Completion: 2024-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy	Paclitaxel plus carboplatin	50.4Gy/28Fx; Paclitaxel plus carboplatin
chemoradiotherapy	radiotherapy	50.4Gy/28Fx; Paclitaxel plus carboplatin
radiotherapy	radiotherapy	61.2Gy/34Fx

Primary Outcome Measures

Name	Time	Method
overall survival difference of definitive radiotherapy and chemoradiotherapy groups	3-year	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.

Secondary Outcome Measures

Name	Time	Method
radiation side effects	acute side effects within 3 months, late side effects for 3 months later	Record the radiation side effects including acute and late side effects.
cancer specific survival	3-year	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.
difference of quality of life between different groups	the period of treatment within 7 weeks and follow up time with an average of 3months	Assess the quality of life through life quality questionnaire.

Trial Locations

Locations (3)

Fudan Universtiy Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Huadong Hospital; 🇨🇳 Shanghai, Shanghai, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China