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

Primary Purpose

Esophageal Squamous Cell Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Having signed informed consent
Age ≥18 years old
Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
Sex is not limited
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)
Karnofsky performance status ≥80
Life expectancy of ≥ 3 month
WBC > 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.5 times ULN
No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃；
Normal ECG and heart function
Fertile patients must use effective contraception
Good compliance

Exclusion Criteria:

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

Sites / Locations

Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sequential treatment

Arm Description

paclitaxel/cisplatin treatment and radiotherapy

Outcomes

Primary Outcome Measures

progression free survival

the follow-up visit of PFS will be performed every 2 cycles

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02016274

First Posted

December 7, 2013

Last Updated

December 13, 2013

Sponsor

Shen Lin

1. Study Identification

Unique Protocol Identification Number

NCT02016274

Brief Title

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

Official Title

Sequential Paclitaxel Plus Cisplatin Chemotherapy and Radiotherapy as First Line Treatment for Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shen Lin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before, the combination of paclitaxel with cisplatin 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 metastatic esophageal carcinoma to observe the efficacy and safety of the combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sequential treatment

Arm Type

Experimental

Arm Description

paclitaxel/cisplatin treatment and radiotherapy

Intervention Type

Other

Intervention Name(s)

Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy

Intervention Description

Sequential paclitaxel/cisplatin chemotherapy and radiotherapy

Primary Outcome Measure Information:

Title

progression free survival

Description

the follow-up visit of PFS will be performed every 2 cycles

Time Frame

1 year

Secondary Outcome Measure Information:

Title

overall survival

Description

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

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

disease control rate

Time Frame

1 year

Title

adverse events

Time Frame

2 years

Title

quality of life

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Having signed informed consent Age ≥18 years old Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months Sex is not limited 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) Karnofsky performance status ≥80 Life expectancy of ≥ 3 month WBC > 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.5 times ULN No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃； Normal ECG and heart function Fertile patients must use effective contraception Good compliance Exclusion Criteria: Previous treatment of palliative chemotherapy Known hypersensitivity to Paclitaxel,Cisplatin Only with Brain or bone metastasis No measurable lesions, eg. pleural fluid and ascites Suffer from severe heart disease or disease with other important organs Chronic diarrhea or renal dysfunction Pregnancy or lactation period Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea Mentally abnormal or disable cognition,including CNS metastasis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Shen, MD

Phone

86-10-88196561

lin100@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhihao Lu, MD

Phone

86-10-88196561

pppeirain@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Shen, MD

Organizational Affiliation

Peking Universtiy Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lin Shen, MD

Phone

86-10-88196561

lin100@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Zhihao Lu, MD

Phone

86-10-88196561

pppeirain@126.com

First Name & Middle Initial & Last Name & Degree

Lin Shen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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