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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519905
• Other study ID #: ESO-Shanghai15
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 2027

Study information

• Verified date: October 2021
• Source: Fudan University
• Contact: Kuaile Zhao, doctor
• Phone: 18017312534
• Email: kuaile_z[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 76 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Esophageal Squamous Cell Carcinoma
• Survival

Intervention

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

Radiation:
• radiotherapy
Different radiotherapy dose in different groups.

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Fudan Universtiy Shanghai Cancer Center	Shanghai	Shanghai
China	Huadong Hospital	Shanghai	Shanghai

Sponsors (9)

Lead Sponsor	Collaborator
Fudan University	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

Country where clinical trial is conducted

China, 

Outcome

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