Chemoradiation and Panitumumab for Esophageal Cancer (NCT01077999) | Clinical Trial Compass
CompletedPhase 2
Chemoradiation and Panitumumab for Esophageal Cancer
Netherlands78 participantsStarted 2010-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage of pathologic complete responses
Timeframe: 6 weeks after the completion of the chemoradiation
Trial details
NCT IDNCT01077999
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)