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A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Phase 3
18 Years
74 Years
Open (Enrolling)
Esophageal Cancer

Thank you

Trial Information

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery



- To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel,
cisplatin, and radiotherapy improves overall survival compared with paclitaxel,
cisplatin, and radiotherapy alone in patients with esophageal cancer treated without


- To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and
radiotherapy improves local control by increasing the clinical complete response and
decreasing local recurrence in these patients.

- To evaluate adverse events in these patients.

- To evaluate endoscopic complete response rates in these patients.

- To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy
improves the Esophageal Cancer Subscale score of the FACT-E quality of life tool.

- To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the
primary endpoint supports the primary hypothesis.

OUTLINE: This is a multicenter study. Patients are stratified according to histology
(adenocarcinoma* vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of
celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.

NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

- Arm I: Patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and
cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo
radiotherapy once daily, 5 days a week, for 5½ weeks for a total dose of 50.4Gy.

- Arm II: Patients receive paclitaxel and cisplatin as in arm I. Patients also undergo
radiotherapy as in arm I.

Patients undergo endoscopy 6 to 8 weeks after completion of chemoradiotherapy. Quality of
life is assessed at baseline, within 1 week of post-treatment endoscopy, and at 1 and 2
years from beginning of study treatment.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


- Histologically confirmed primary squamous cell or adenocarcinoma* of the esophagus or
gastroesophageal junction

- Patients with involvement of the gastroesophageal junction with Siewert type I
or II tumors (tumors arising from the distal esophagus and involving the
esophagogastric junction or tumors starting at the esophagogastric junction and
involving the cardia) are eligible

- Patients with cervical esophageal carcinoma are eligible

- Patients with celiac, perigastric, mediastinal, or supraclavicular adenopathy
are eligible NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

- Stage T1, N1, M0; T2-4, Any N, M0; or Any T, Any N, M1a disease based on
history/physical examination, endoscopy with biopsy, AND PET/PET-CT scan or
chest/abdominal CT scan within 6 weeks prior to registration

- Disease must be encompassed in a radiotherapy field

- No evidence of tracheoesophageal fistulas or invasion into the trachea or major

- Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo
bronchoscopy to exclude fistula


- Zubrod performance status 0-2

- ANC ≥ 1,500/mm³

- Platelets ≥ 100,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL

- Creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 3 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Total intake (oral/enteral) must be ≥ 1,500 kCal/day

- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in
situ of the breast, oral cavity, or cervix) unless disease-free for ≥ 2 years

- No prior allergic reaction to the study drugs

- No prior severe infusion reaction to a monoclonal antibody

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 3 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Acquired immune deficiency syndrome based upon current CDC definition

- HIV testing is not required for entry into this study


- No prior systemic chemotherapy for esophageal cancer (prior chemotherapy for another
cancer allowed)

- No prior therapy that specifically and directly targets the EGFR pathway

- No prior platinum-based and/or paclitaxel-based therapy

- No prior radiotherapy that would result in overlap of planned study radiotherapy

- No concurrent investigational agent

- No concurrent cytotoxic agent

- No other concurrent radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival (failure: death due to any cause)

Safety Issue:


Principal Investigator

Mohan Suntharalingam, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center



Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

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



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