Clinical trial NCT02016287: Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer
Official title: Sequential Paclitaxel Chemotherapy and Radiotherapy as First Line Treatment for Elderly Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Cancer
Elderly Patients
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 69
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in China. In the investigators phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and safety of the combination.


Eligibility criteria: Inclusion Criteria:

1. Having signed informed consent Age more than 69 years old
2. Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy;
3. No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
4. Sex is not limited
5. Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
6. Karnofsky performance status ≥80
7. Life expectancy of ≥ 3 month
8. WBC \> 3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 1.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.0 times ULN
9. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
10. Normal ECG and heart function
11. Fertile patients must use effective contraception Good compliance

Exclusion Criteria:

1. Previous treatment of palliative chemotherapy
2. Known hypersensitivity to Paclitaxel,Cisplatin
3. Only with Brain or bone metastasis
4. No measurable lesions, eg. pleural fluid and ascites
5. Suffer from severe heart disease or disease with other important organs Chronic diarrhea or renal dysfunction
6. Other previous malignancy within 5 year, except non-melanoma skin cancer
7. Mentally abnormal or disable cognition,including CNS metastasis

Primary outcomes:
measure: progression free survival
timeFrame: 1 year
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
Other outcomes:
measure: disease control rate
timeFrame: 1 year
measure: adverse events
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking Universtiy Cancer Hospital
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: