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Phase 2 N=55 Treatment

Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

Esophageal Cancer

Enrolled (actual)
55
Serious AEs
3.6%
Results posted
Feb 2011
Primary outcome: Primary: Number of Participants With Overall Response Rate (RR) — 44 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
cetuximab (Erbitux) (Drug); Paclitaxel (Drug); Cisplatin (Drug); Radiation (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Shandong Cancer Hospital and Institute
Primary completion
Jul 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Overall Response Rate (RR)
44
SECONDARY
Number of Participants With Toxicity
55
SECONDARY
Participants With Overall Survival (OS) at 1 Year
SECONDARY
Participants With Overall Survival (OS) at 3 Year
SECONDARY
Participants With Progression Free Survival (PFS)
SECONDARY
Number of Participants With K-ras Gene Mutation
53

Summary

The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

Eligibility Criteria

Inclusion Criteria

  • Inpatients or outpatients, ≥ 18 years of age
  • Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following criteria (AJCC Staging System)
  • cervical esophageal carcinoma, stage Ⅱ-Ⅲ
  • upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused and patient medically able to tolerate chemo-radiation.
  • Evidence of unidimensional measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST).
  • ECOG Performance status of 0-1
  • Effective contraception for both male and female patients if the risk of conception exists
  • Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl
  • Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
  • Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x ULN
  • Tumor tissue available for KRAS biomarker test
  • Signed written informed consent prior to study entry

Exclusion Criteria

  • Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
  • Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol
  • Multiple primary carcinomas of the esophagus
  • Pregnancy (confirmed by serum or urine β-HCG) or lactation period;
  • Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
  • Unable to comprehend the study requirements or who are not likely to comply with the study parameters;
  • Distant metastasis
  • Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in situ, or malignant disease, free for ≥ 5 years
  • Known grade 3 or 4 allergic reaction to any of the study treatment
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00815308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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