Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

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

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nab-paclitaxel group

Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT

Group Type EXPERIMENTAL

nab-paclitaxel group

Intervention Type DRUG

Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT

Interventions

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nab-paclitaxel group

Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No