Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02762474

Enrollment

Registered

2016-05-05

Start date

2014-07-31

Completion date

2017-12-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

nab-paclitaxel, IMRT, esophageal cancer

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.

Interventions

DRUGnab-paclitaxel group

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progress free survival	3 years

Secondary

Measure	Time frame
Overall survival	3 years
CTCAE 4.0 toxicity	6 months

Countries

China

Contacts

Primary ContactPing Wang, M. D.

wangping@tjmuch.com0862223340123

Backup ContactPing Wang, M. D.

wangping@tjmuch.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026