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A Phase II Study of Combining Cetuximab Plus Twice Weekly Paclitaxel/Cisplatin Concurrent Chemoradiotherapy (TP-CCRT) Followed With or Without Esophagectomy for Loco-regional Esophageal Squamous Cell Carcinoma (ESCC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

A Phase II Study of Combining Cetuximab Plus Twice Weekly Paclitaxel/Cisplatin Concurrent Chemoradiotherapy (TP-CCRT) Followed With or Without Esophagectomy for Loco-regional Esophageal Squamous Cell Carcinoma (ESCC)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Yung-Chie Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

200803088M

NCT ID:

NCT01034189

Start Date:

October 2008

Completion Date:

June 2012

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Chemoradiotherapy
  • Paclitaxel
  • Cetuximab
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

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