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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04519905
Other study ID # ESO-Shanghai15
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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