Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

Phase 1

• Conditions: Esophageal Cancer
• Interventions: Drug: nab-paclitaxel group

• Registration Number: NCT02762474
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2016-03
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nab-paclitaxel group	nab-paclitaxel group	Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT

Primary Outcome Measures

Name	Time	Method
Progress free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years
CTCAE 4.0 toxicity	6 months

Trial Locations

Locations (1)

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China