Menu
Recruiting NCT04519905

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

No phase Interventional Esophageal Squamous Cell Carcinoma Chemoradiotherapy Survival

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paclitaxel plus carboplatin, radiotherapy.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Survival. Basic parameters: from 76 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Paclitaxel plus carboplatin
    Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
  • Radiation radiotherapy
    Different radiotherapy dose in different groups.

Primary outcome measures

  • overall survival difference of definitive radiotherapy and chemoradiotherapy groups [Time frame: 3-year]
Secondary outcome measures (3)
  • difference of quality of life between different groups [Time frame: the period of treatment within 7 weeks and follow up time with an average of 3months]
  • radiation side effects [Time frame: acute side effects within 3 months, late side effects for 3 months later]
  • cancer specific survival [Time frame: 3-year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Jiangsu Cancer Hospital — Nanjing
  • Huadong Hospital — Shanghai
  • Fudan Universtiy Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT04519905 · ESO-Shanghai15

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗