Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04519905

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Chemoradiotherapy Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Survival

Age range

76 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiangsu Cancer Hospital, Nanjing, Jiangsu, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel plus carboplatin

Drug

Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw

Radiotherapy

Radiation

Different radiotherapy dose in different groups.

Primary outcomes

  1. overall survival difference of definitive radiotherapy and chemoradiotherapy groups

    Time frame: 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 outcomes

  1. 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

    Assess the quality of life through life quality questionnaire.

  2. radiation side effects

    Time frame: acute side effects within 3 months, late side effects for 3 months later

    Record the radiation side effects including acute and late side effects.

  3. cancer specific survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kuaile Zhao, doctor

CONTACT

[email protected]

18017312534 ext. 021-64175590

ying jia Deng, doctor

CONTACT

[email protected]

18017312829

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Fujian Cancer Hospital
  • Gansu Cancer Hospital
  • Huadong Hospital
  • Jiangsu Cancer Institute & Hospital
  • Ningbo No.2 Hospital
  • Taihe Hospital
  • The First Affiliated Hospital of Xiamen University
  • Wuxi No. 4 People's Hospital

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Aug 20, 2020
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.