Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose
DGRT
Managing the Real Dose: Evaluating the Impact on Gastric Filling on the Delivered Radiation Dose in Gastrooesophageal Junction Tumors
2 other identifiers
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 6, 2015
October 1, 2015
8 months
March 13, 2014
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
Thoracic margin evaluation
weekly during radio-and chemotherapy (5weeks)
Stomach variation
Weekly during radio-and chemotherapy (5 weeks)
Study Arms (2)
without feeding/fluid instructicon
NO INTERVENTIONTen patients treated with preoperative chemoradiotherapy without feeding/fluid instructions
with feeding/fluid instructions
EXPERIMENTALTen patients treated with preoperative chemoradiotherapy with feeding/fluid instructions
Interventions
No additional intervention besides standard treatment prescription will be added. Investigators foresee daily kV cone beam CT matching (already standard in house). this subgroup of 10 patients will be asked not to eat or drink carbonated fluids three hours before CT simulation and daily treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Thoracic adenocarcinoma/squamous cell carcinoma
- Palliative treatment for the oesophageal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MAASTRO clinic
Maastricht, 6229 ET, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Lambin, MD, PhD
Maastricht Radiation Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2014
First Posted
May 2, 2014
Study Start
March 1, 2014
Primary Completion
November 1, 2014
Study Completion
September 1, 2015
Last Updated
October 6, 2015
Record last verified: 2015-10