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

Fudan University

Status: Enrolling

Conditions: Survival; Chemoradiotherapy; Esophageal Squamous Cell Carcinoma

Treatments: Drug: Paclitaxel plus carboplatin; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04519905

ESO-Shanghai15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 76+ years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

chemoradiotherapy

Experimental group

Description:

50.4Gy/28Fx; Paclitaxel plus carboplatin

Treatment:

Radiation: radiotherapy

Drug: Paclitaxel plus carboplatin

radiotherapy

Active Comparator group

Description:

61.2Gy/34Fx

Treatment:

Radiation: radiotherapy