Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer

Elderly Patients Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02016287
• Other study ID #: CGOG7002
• Secondary ID: CGOG7002
• Status: Recruiting
• Phase: Phase 2
• First received: December 7, 2013
• Last updated: December 13, 2013
• Start date: December 2013
• Est. completion date: July 2016

Study information

• Verified date: December 2013
• Source: Peking University
• Contact: Lin Shen, MD
• Phone: 86-10-88196561
• Email: lin100[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 69 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Elderly Patients
• Esophageal Squamous Cell Cancer
• Neoplasms, Squamous Cell

Intervention

Other:
• Sequential chemotherapy (paclitaxel 80mg/m2 d1,d8) and radiotherapy
Sequential paclitaxel chemotherapy and radiotherapy

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shen Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	disease control rate		1 year	No
Other	adverse events		2 years	Yes
Other	quality of life		2 years	No
Primary	progression free survival	the follow-up visit of PFS will be performed every 2 cycles	1 year	No
Secondary	overall survival	OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost	2 years	No