Chemoradiation and Panitumumab for Esophageal Cancer
Recruitment status was Recruiting
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Purpose
A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of better disease-free and overall survival. Therefore in the investigators trial the investigators will evaluate the pathologic response of panitumumab in combination with neoadjuvant chemoradiation as first line treatment of operable adenocarcinomas, undifferentiated or squamous cell carcinomas of the esophagus.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Carcinoma Adenocarcinoma Esophageal Cancer Gastro-esophageal Junction Cancer |
Drug: carboplatin Drug: Paclitaxel Drug: Panitumumab Radiation: 3-D conformal radiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemoradiation Combined With Panitumumab Followed by Surgery for Patients With Operable Esophageal Cancer |
- Percentage of pathologic complete responses [ Time Frame: 6 weeks after the completion of the chemoradiation ] [ Designated as safety issue: No ]
- R0 resection rate [ Time Frame: the pathologist will determine the resection rate ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Every 3 months during the first 2 years after surgery, and every 6 months thereafter. ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: Weekly during chemoradiation. After surgery: every 3 months during the first 2 years after surgery, and every 6 months thereafter. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 76 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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Drug: carboplatin
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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%.
Contacts and Locations| Contact: Hanneke Wilmink, MD PhD | +31-20-5665955 | j.w.wilmink@amc.uva.nl |
| Contact: Dick Richel, MD PhD | +31-20-5665955 | d.j.richel@amc.uva.nl |
| Netherlands | |
| Academic Medical Center | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Hanneke Wilmink, MD PhD +31-20-5665955 j.w.wilmink@amc.uva.nl | |
| Principal Investigator: Hanneke Wilmink, MD PhD | |
| Principal Investigator: | Hanneke Wilmink, MD PhD | Academic Medical Center, Amsterdam |
More Information
No publications provided
| Responsible Party: | J.W. Wilmink, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01077999 History of Changes |
| Other Study ID Numbers: | AMCmedon08/381 |
| Study First Received: | February 25, 2010 |
| Last Updated: | September 7, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
chemoradiation panitumumab esophageal cancer Resectable squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus or gastro esophageal junction |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Carboplatin Paclitaxel Antibodies, Monoclonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013