Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

Tianjin Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Esophageal Cancer

Treatments: Drug: nab-paclitaxel group

Study type: Interventional

Funder types: Other

Identifiers

NCT02762474

ESO20140703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

nab-paclitaxel group

Experimental group

Description:

Weekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT

Treatment:

Drug: nab-paclitaxel group