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

NCT01034189 | Unknown Phase 2

• 1 other identifier: 200803088M
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Cancer

Keywords

Esophageal cancer; Chemoradiotherapy; Paclitaxel; Cetuximab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pathologic complete response (pCR).

  2 years

• Disease-free survival.

  2 years

• Safety and toxicity of cetuximab combined with twice weekly TP-CCRT, followed by surgery.

  2 years

Study Arms (1)

Targeted therapy

EXPERIMENTAL

Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy

Drug: Cetuximab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Cetuximab DRUG

Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3\~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT).

Also known as: Erbitux

Targeted therapy

Paclitaxel DRUG

T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT.

Targeted therapy

Cisplatin DRUG

P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT.

Targeted therapy

Radiotherapy RADIATION

Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.

Targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven squamous cell carcinoma of esophagus.
• 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.
• Age ≥ 18 years old.
• Performance status ECOG 0\~2.
• 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.
• 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).
• Adequate renal function: Creatinine ≤1.5 mg/dl
• Written informed consent.

You may not qualify if:

• Invasion to surrounding organ (T4 disease).
• Adenocarcinoma of gastroesophageal (GE) junction.
• Prior thoracic irradiation.
• Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
• 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.
• 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.
• Estimated life expectancy less than 3 months.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Related Publications (1)

• Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.

  PMID: 26313683 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cetuximab; Paclitaxel; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Yung-Chie Lee, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Hung Hsu, M.D., Ph.D.

CONTACT

886-2-23123456; chihhunghu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2012
• Last Updated: December 17, 2009

Record last verified: 2009-12

Locations

TW (1)