Adenocarcinoma Clinical Trial
— DGRTOfficial title:
Managing the Real Dose: Evaluating the Impact on Gastric Filling on the Delivered Radiation Dose in Gastrooesophageal Junction Tumors
This study will prospectively collect patients undergoing the standard CROSS regimen in the neoadjuvant setting of the treatment for gastro-oesophageal cancer. The investigators will focus on the potential geometric differences between the OAR and target volume on the initial planning CT and on the kilovolt (kV) cone-beam computed tomography (CBCT). They expect a potential difference in the abdominal part of the planned target volume (PTV) and/or gastro-oesophageal junction part. Furthermore, the impact of gastric filling , potential tumor regression and the accuracy of 5 mm PTV margin in the thoracic PTV will be monitored.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically proven adenocarcinoma of the gastro-oesophageal junction - Age 18 years or older - International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen - WHO 0-2 Exclusion Criteria: - Thoracic adenocarcinoma/squamous cell carcinoma - Palliative treatment for the oesophageal cancer |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | MAASTRO clinic | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology | Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients in which the CTV was not covered | Proportion of patients in which the CTV was not covered (CTV D99, V95, Dmean) with and without different filling status of the stomach in patients treated with neoadjuvant chemoradiotherapy for gastroesophageal cancer | Weekly during radio-and chemotherapy (5 weeks) | No |
Secondary | Thoracic margin evaluation | evaluation if a CTV-PTV margin of 5 mm in the thoracic part of the target volume is sufficient | weekly during radio-and chemotherapy (5weeks) | No |
Secondary | Stomach variation | stomach movement evaluation on a weekly cone beam CT during chemo radiotherapy with and without feeding/fluid instructions. | Weekly during radio-and chemotherapy (5 weeks) | No |
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