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

Not Applicable

Completed

• Conditions: Adenocarcinoma
• Interventions: Other: with feeding/fluid instruction

• Registration Number: NCT02130011
• Lead Sponsor: Maastricht Radiation Oncology

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.

Detailed 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-02
• Primary Completion: 2014-11
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with feeding/fluid instructions	with feeding/fluid instruction	Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions

Primary Outcome Measures

Name	Time	Method
Proportion of patients in which the CTV was not covered	Weekly during radio-and chemotherapy (5 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Thoracic margin evaluation	weekly during radio-and chemotherapy (5weeks)	evaluation if a CTV-PTV margin of 5 mm in the thoracic part of the target volume is sufficient
Stomach variation	Weekly during radio-and chemotherapy (5 weeks)	stomach movement evaluation on a weekly cone beam CT during chemo radiotherapy with and without feeding/fluid instructions.

Trial Locations

Locations (1)

MAASTRO clinic; 🇳🇱 Maastricht, Netherlands