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

NCT ID: NCT02016274

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Squamous Cell Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sequential treatment

paclitaxel/cisplatin treatment and radiotherapy

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Sequential paclitaxel/cisplatin chemotherapy and radiotherapy

Interventions

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

Sequential paclitaxel/cisplatin chemotherapy and radiotherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shen Lin

OTHER

Sponsor Role lead

Responsible Party

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Shen Lin

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Universtiy Cancer Hospital

Locations

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Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin Shen, MD

Role: CONTACT

Phone: 86-10-88196561

Email: [email protected]

Zhihao Lu, MD

Role: CONTACT

Phone: 86-10-88196561

Email: [email protected]

Facility Contacts

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Lin Shen, MD

Role: primary

Zhihao Lu, MD

Role: backup

Other Identifiers

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CGOG7001

Identifier Type: REGISTRY

Identifier Source: secondary_id

CGOG7001

Identifier Type: -

Identifier Source: org_study_id