Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762474
• Other study ID #: ESO20140703
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 3, 2016
• Last updated: February 6, 2017
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Ping Wang, M. D.
• Phone: 0862223340123
• Email: wangping[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.

Description:

Esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. Concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. Paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. Compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. According to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a(AJCC 2002)

2. ECOG performance status scale 0-1

3. at least 1 measurable target lesions

4. white blood count = 3,500/mm3, absolute neutrophil count = 1,500/mm3, platelet count = 100,000/mm3, hemoglobin count = 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase = 2.5 ULN, serum albumin = 30g/L, serum creatinine = 1.5 ULN; and

5. normal cardiac function with no severe heart disease.

Exclusion Criteria:

1. history of esophagectomy

2. pregnancy or breast feeding

3. past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;

4. concomitant treatment with other anticancer drugs.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• nab-paclitaxel group
Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival		3 years
Secondary	Overall survival		3 years
Secondary	CTCAE 4.0 toxicity		6 months