Clinical trial NCT04519905: Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Official title: Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Survival
Keywords: esophageal squamous cell carcinoma
elderly patients
chemoradiotherapy
definitive radiotherapy
survival
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: Jiangsu Cancer Institute & Hospital
name: Gansu Cancer Hospital
name: The First Affiliated Hospital of Xiamen University
name: Fujian Cancer Hospital
name: Taihe Hospital
name: Wuxi No. 4 People's Hospital
name: Ningbo No.2 Hospital
First posted: 2020-08-20
Enrollment: 320
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: overall survival difference of definitive radiotherapy and chemoradiotherapy groups
timeFrame: 3-year
Secondary outcomes:
measure: difference of quality of life between different groups
timeFrame: the period of treatment within 7 weeks and follow up time with an average of 3months
measure: radiation side effects
timeFrame: acute side effects within 3 months, late side effects for 3 months later
measure: cancer specific survival
timeFrame: 3-year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Huadong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Kuaile Zhao, doctor
role: STUDY_CHAIR
affiliation: Huadong Hospital
name: Xiangpeng Zheng, doctor
role: PRINCIPAL_INVESTIGATOR
References: