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

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Cetuximab

Paclitaxel

Cisplatin

Radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Chemoradiotherapy, Paclitaxel, Cetuximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Invasion to surrounding organ (T4 disease).
Distant metastasis, except M1a disease listed in the inclusion criteria 2-C.
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.

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Targeted therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pathologic complete response (pCR).

Disease-free survival.

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

Full Information

NCT ID

NCT01034189

First Posted

December 16, 2009

Last Updated

December 16, 2009

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01034189

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

Esophageal cancer, Chemoradiotherapy, Paclitaxel, Cetuximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Targeted therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Pathologic complete response (pCR).

Time Frame

2 years

Title

Disease-free survival.

Time Frame

2 years

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Invasion to surrounding organ (T4 disease). Distant metastasis, except M1a disease listed in the inclusion criteria 2-C. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

886-2-23123456

Ext

67680

chihhunghu@ntu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yung-Chie Lee, M.D.

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

886-2-23123456

Ext

67680

chihhunghsu@ntu.edu.tw

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

26313683

Citation

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.

Results Reference

derived

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

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