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Status unknownNCT01034189Updated Dec 17, 2009

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

A Phase 2 interventional study of Cetuximab and Paclitaxel in Esophageal Cancer, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-17.

Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal cancer
  • Chemoradiotherapy
  • Paclitaxel
  • Cetuximab
03

In context

Esophageal Neoplasms

1,592 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's planned enrollment of 62 is close to the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 570 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Targeted therapy

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

    Drug: Cetuximab · Drug: Paclitaxel · Drug: Cisplatin · Radiation: Radiotherapy

Interventions

  • DrugCetuximab

    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

  • DrugPaclitaxel

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

  • DrugCisplatin

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

  • RadiationRadiotherapy

    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.

06

What researchers measure

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).

    Time frame: 2 years

Secondary outcomes

  1. Pathologic complete response (pCR).

    Time frame: 2 years

  2. Disease-free survival.

    Time frame: 2 years

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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
    • Chih-Hung Hsu, M.D., Ph.D. · Contact · chihhunghsu@ntu.edu.tw · 886-2-23123456
    • Chih-Hung Hsu, M.D., Ph.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26313683 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01034189
Lead sponsor
National Taiwan University Hospital
First posted
Dec 17, 2009
Start date
Oct 2008
Primary completion
Dec 2010 (estimated)
Completion
Jun 2012 (estimated)
Last update
Dec 17, 2009

Study contacts

Chih-Hung Hsu, M.D., Ph.D.
Contact
chihhunghu@ntu.edu.tw
886-2-23123456 ext. 67680
Yung-Chie Lee, M.D.
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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