Cetuximab/Paclitaxel/Cisplatin Concurrent Chemoradiotherapy Followed by Esophagectomy for Loco-regional Esophageal Cancer

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Drug: Cetuximab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

• Registration Number: NCT01034189
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (TP-CCRT) as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Detailed Description

We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma.

Study Timeline

• Study Start: 2008-10
• Status Verified: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Last Update Submitted: 2009-12-16
• Study First Posted: 2009-12-17
• Last Update Posted: 2009-12-17
• Primary Completion: 2010-12
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Pathologically proven squamous cell carcinoma of esophagus.

2. Loco-regional diseases, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (6th edition) in 2002, fulfilling one of the following criteria:

   A. T3, N0, M0; B. T1-3, N1, M0; C. T1-3 or N0-1, M1a will be eligible provided the lesions could be covered by appropriate radiation fields.

3. Age ≥ 18 years old.

4. Performance status ECOG 0~2.

5. Adequate bone marrow reserves, defined as:

   A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.

6. Adequate liver function reserves, defined as:

   A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 1.5 x upper limit of normal (ULN).

7. Adequate renal function: Creatinine ≤1.5 mg/dl

8. Written informed consent.

Exclusion Criteria

1. Invasion to surrounding organ (T4 disease).

2. Distant metastasis, except M1a disease listed in the inclusion criteria 2-C.

3. Adenocarcinoma of gastroesophageal (GE) junction.

4. Prior thoracic irradiation.

5. Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.

6. Prior malignancy, except for the following:

   A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. Note: previously treated aerodigestive squamous cell carcinoma is not allowed.

7. Significant co-morbid disease, which prohibit the conduction of chemotherapy, concurrent chemoradiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.

8. Estimated life expectancy less than 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted therapy	Radiotherapy	Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
Targeted therapy	Cetuximab	Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
Targeted therapy	Cisplatin	Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy
Targeted therapy	Paclitaxel	Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy

Primary Outcome Measures

Name	Time	Method
To determine the clinical response rate in patients with loco-regional esophageal squamous cell carcinoma treated with cetuximab combined with twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (C-TP-CCRT, 40 Gy).	2 years

Secondary Outcome Measures

Name	Time	Method
Safety and toxicity of cetuximab combined with twice weekly TP-CCRT, followed by surgery.	2 years
Disease-free survival.	2 years
Pathologic complete response (pCR).	2 years

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan