- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01077999
Chemoradiation and Panitumumab for Esophageal Cancer
Chemoradiation Combined With Panitumumab Followed by Surgery for Patients With Operable Esophageal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase II, non-randomized trial. Eligible subjects will be treated with panitumumab plus carboplatin, paclitaxel and radiotherapy followed by surgical resection of the esophagus.
Panitumumab administration schedule: Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, prior to administration of chemotherapy at a dose of 6 mg/kg on day 1, 15 and 29. If the first infusion is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.
Chemotherapy regimen: Paclitaxel 50 mg/m2 and Carboplatin AUC = 2 will be given by intravenous infusion on days 1, 8, 15, 22 and 29. Both drugs will be infused over one hour.
Radiotherapy treatment: A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy. All patients will be radiated by external beam radiation, using 3-D conformal radiation technique.
Surgery: Surgery will be performed preferably within 6 weeks after the completion of the chemoradiation and panitumumab. For carcinomas distal of the tracheal bifurcation but proximal to the gastro-esophageal junction, a transthoracic approach is preferred. For distal tumors involving the gastro-esophageal junction a transhiatal esophageal resection is preferred. A wide local excision including the N1 lymph nodes is carried out in both techniques including a standard excision of the lymph nodes around the coeliac axis. The continuity of the digestive tract will be restored by a gastric tube reconstruction or colonic interposition procedure with an anastomosis in the neck.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Amsterdam, Netherlands, 1105 AZ
- Academic Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction
- Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and CT scan of neck, thorax and abdomen.
- T1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible
- Tumor length longitudinal ≤ 10 cm and radial ≤ 5 cm
- If tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach. Gastric cancers with minor involvement of the GE junction or distal esophagus are not eligible
- No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
- Non pregnant, non-lactating female patients, not planning to become pregnant within 6 months after the end of treatment.
- Age ≥ 18 and ≤ 75
- ECOG performance status 0 or 1
- Adequate hematological, renal, hepatic and pulmonary functions
- Written, voluntary informed consent
- Patients must be accessible to follow up and management in the treatment center
Exclusion Criteria:
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment
- Pregnancy (positive serum pregnancy test) and lactation
- Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- Previous chemotherapy, radiotherapy, treatment with an anti-EGFR antibody or with small molecule EGFR inhibitors
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before randomization
- Pulmonary fibrosis
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Inadequate caloric- and/or fluid intake
- Weight loss > 15%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Carboplatin + paclitaxel + radiotherapy
Carboplatin AUC = 2, Paclitaxel 50 mg/m2 (both weekly) , a total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
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Carboplatin AUC = 2 , weekly.
Paclitaxel 50 mg/m2, weekly
A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
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Experimental: Carboplatin+ paclitaxel+ panitumumab+ radiotherapy
Carboplatin AUC = 2, Paclitaxel 50 mg/m2 (both weekly) , a total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
Panitumumab panitumumab: 6mg/kg in weeks 1-3-5.
|
Carboplatin AUC = 2 , weekly.
Paclitaxel 50 mg/m2, weekly
A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
panitumumab: 6mg/kg in weeks 1-3-5.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of pathologic complete responses
Time Frame: 6 weeks after the completion of the chemoradiation
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6 weeks after the completion of the chemoradiation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
R0 resection rate
Time Frame: the pathologist will determine the resection rate
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the pathologist will determine the resection rate
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Progression free survival
Time Frame: Every 3 months during the first 2 years after surgery, and every 6 months thereafter.
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Every 3 months during the first 2 years after surgery, and every 6 months thereafter.
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Toxicity profile
Time Frame: Weekly during chemoradiation. After surgery: every 3 months during the first 2 years after surgery, and every 6 months thereafter.
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Weekly during chemoradiation. After surgery: every 3 months during the first 2 years after surgery, and every 6 months thereafter.
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Collaborators and Investigators
Investigators
- Principal Investigator: Hanneke Wilmink, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Adenocarcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Carboplatin
- Paclitaxel
- Panitumumab
Other Study ID Numbers
- AMCmedon08/381
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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