Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose

Adenocarcinoma Clinical Trial

— DGRT  

Official title:

Managing the Real Dose: Evaluating the Impact on Gastric Filling on the Delivered Radiation Dose in Gastrooesophageal Junction Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130011
• Other study ID #: DGRT
• Secondary ID: 14-01-15/01-inte
• Status: Completed
• Phase: N/A
• First received: March 13, 2014
• Last updated: October 5, 2015
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Description:

Optimal radiotherapy planning and delivery is essential for irradiation of gastro-oesophageal junction tumors. There is a need for individualized radiotherapy delivery to the upper abdomen, because of mobility. Likewise, controlling gastric filling by instructing patients about fluid and food intake before treatment, may contribute to positional reproducibility. There is evidence that missing microscopic disease in treating the clinical target volume (CTV) results in a worse prognostic outcome. The investigators want to evaluate wether positional difference of stomach, with and without fasting prescription, has an impact of the delivered dose. They will focus on the part of the CTV extending in the stomach. The investigators hypothesize that measurement of the dose using verification kilovoltage cone beam CTs will provide information on potential cold/hot spots of dose delivery and monitor potential geometric differences during treatment. This may result in a suboptimal treatment and a reconsideration of matching target volume on soft tissue instead of bony landmarks. The investigators will evaluate the first clinical results with DGRT in patients with esophageal cancer.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma

Intervention

Other:
• with feeding/fluid instruction
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

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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