Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+ Esophageal Carcinoma (TRAP)
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|ClinicalTrials.gov Identifier: NCT02120911|
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Carcinoma||Drug: Pertuzumab, trastuzumab||Phase 1 Phase 2|
Objective of the study:
Assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery.
This is a non-randomized feasibility study with Paclitaxel (T), Carboplatin (C), Pertuzumab (P). Trastuzumab (H), and radiation (RT) followed by surgical resection of the oesophagus.
Patients (male/female) with histologically proven adenocarcinoma of the intrathoracic esophagus or gastro esophageal junction, age >18 and <75 years.
Intervention (if applicable):
Paclitaxel 50 mg/m2 and Carboplatin AUC = 2 will be given by intravenous infusion on days 1, 8, 15, 22 and 29.
Trastuzumab will be administered at a dose of 4 mg/kg on day 1, followed by 2 mg/kg at wk 2-6. From wk 7 onwards trastuzumab is administered at a dose of 6 mg/kg every 3 weeks. Pertuzumab will be given 840 mg intravenously at each administration.
Thus, trastuzumab and pertuzumab will be continued during eight weeks after the end of chemoradiation. Surgery will be planned in or around week 14, approximately eight weeks after the end of chemoradiation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+Esophageal Carcinoma: the TRAP Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: Pertuzumab, trastuzumab
Drug: Pertuzumab, trastuzumab
Pertuzumab and trastuzumab will be combined with standard chemoradiation with carboplatin and paclitaxel.
- % of patients completing trastuzumab and pertuzumab treatment. [ Time Frame: up to 14 weeks after start of treatment ]See title
- Toxicity of pertuzumab and trastuzumab alone and in combination with chemoradiation [ Time Frame: up to 14 weeks after start of treatment ]
- Number of post-operative complications [ Time Frame: up to 3 months after surgery ]
- Pathological response [ Time Frame: up to 2 weeks after surgery ]
- R0 resection rate [ Time Frame: up to 2 weeks after surgery ]
- Pharmacokinetics of pertuzumab and trastuzumab [ Time Frame: up to 14 weeks after start of treatment ]
- Relation between exposure and effect (safety and efficacy). [ Time Frame: up to 3 months after surgery ]
- Biomarker analyses [ Time Frame: up to 3 months after surgery ]
- SUV of pre-treatment trastuzumab-PET [ Time Frame: up to two weeks after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120911
|Academic Medical Center, Medical Oncology|
|Amsterdam, Netherlands, 1100 DD|
|Principal Investigator:||H. WM van Laarhoven, MD, PhD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|