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A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus

Phase 2/Phase 3
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

A Randomised Phase II/III Multi-Centre Clinical Trial of Definitive Chemotherapy, With or Without Cetuximab, in Carcinoma of the Oesophagus



- To determine whether the addition of cetuximab to definitive chemoradiotherapy
comprising cisplatin, capecitabine, and radiotherapy shows evidence of enhanced overall
survival in patients with carcinoma of the esophagus.

- To determine the safety of this regimen in these patients.

- To determine the feasibility of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV over 2 hours on days 1, 22, 43, and 64 and oral
capecitabine twice daily on days 1-84. Beginning in week 7 patients also undergo
radiotherapy 5 days a week for 5 weeks (weeks 7-11). Treatment continues in the absence
of disease progression or unacceptable toxicity.

- Arm II: Patients receive cisplatin and capecitabine and undergo radiotherapy as in arm
I. Patients also receive cetuximab IV over 1-2 hours on day 1 in weeks 1-12. Treatment
continues in the absence of disease progression or unacceptable toxicity.

Quality of life and health economics are assessed at baseline, during treatment, and at
pre-specified time points during follow-up.

After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then annually for a minimum of 5 years.

Inclusion Criteria


- Histologically confirmed carcinoma of the esophagus

- Adenocarcinoma

- Squamous cell

- Undifferentiated carcinoma

- Siewert type I tumor of the gastroesophageal junction

- Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound
(EUS) and spiral CT scan

- Total disease length (primary and lymph nodes) < 10 cm by EUS

- Not suitable for surgery (either for medical reasons or patient's choice)

- No metastatic disease (i.e., M1a or M1b according to UICC TNM version 6)

- No significant (> 2 cm) extension of tumor into the stomach


- WHO performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm³

- White blood cell count ≥ 2,000/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL (should be corrected to > 10 g/dL before treatment)

- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT/AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Glomerular filtration rate > 40 mL/min OR > 60 mL/min estimated by Cockcroft-Gault

- Adequate cardiac ejection fraction ≥ 40% by MUGA or ECHO

- FEV_1 ≥ 1 L by spirometry

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No malignancy within the past 5 years

- No unstable angina, uncontrolled hypertension, cardiac failure, or other clinically
significant cardiac disease

- No major trauma within the past 4 weeks

- No known dihydropyrimidine dehydrogenase deficiency

- No hearing impairment or sensory-motor neuropathy > grade 2


- See Disease Characteristics

- At least 4 weeks since prior sorivudine and analogues

- At least 4 weeks since prior major surgery

- At least 4 weeks since prior monoclonal antibody

- At least 3 months since prior radiotherapy

- No prior treatment for invasive esophageal carcinoma or gastroesophageal junction
carcinoma (not including photodynamic therapy or laser therapy for high-grade
dysplasia/carcinoma in situ)

- No other prior treatment for this malignancy that would compromise the ability to
deliver definitive mediastinal chemoradiotherapy or compromise survival

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-failure rate at 24 weeks

Safety Issue:


Principal Investigator

Tom Crosby, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Velindre NHS Trust


Medicines and Healthcare Products Regulatory Agency, United Kingdom:

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage IA esophageal cancer
  • stage IB esophageal cancer
  • stage IIA esophageal cancer
  • stage IIB esophageal cancer
  • stage IIIA esophageal cancer
  • stage IIIB esophageal cancer
  • stage IIIC esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms