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

NCT04519905 | Recruiting

• 1 other identifier: ESO-Shanghai15
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

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.

Conditions

Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Survival

Keywords

esophageal squamous cell carcinoma; elderly patients; chemoradiotherapy; definitive radiotherapy; survival

Outcome Measures

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.

  3-year

Secondary Outcomes (3)

• difference of quality of life between different groups

  the period of treatment within 7 weeks and follow up time with an average of 3months

• radiation side effects

  acute side effects within 3 months, late side effects for 3 months later

• cancer specific survival

  3-year

Study Arms (2)

chemoradiotherapy

EXPERIMENTAL

50.4Gy/28Fx; Paclitaxel plus carboplatin

Drug: Paclitaxel plus carboplatin; Radiation: radiotherapy

radiotherapy

ACTIVE COMPARATOR

61.2Gy/34Fx

Radiation: radiotherapy

Interventions

Paclitaxel plus carboplatin DRUG

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

chemoradiotherapy

radiotherapy RADIATION

Different radiotherapy dose in different groups.

chemoradiotherapy; radiotherapy

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• 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

Study Sites (3)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

RECRUITING

Huadong Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Therapeutics

Study Officials

• Kuaile Zhao, doctor

  Fudan University

  STUDY CHAIR

• Xiangpeng Zheng, doctor

  Huadong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuaile Zhao, doctor

CONTACT

18017312534; kuaile_z@sina.com

ying jia Deng, doctor

CONTACT

18017312829; dengjiaying3@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: January 6, 2020
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)