Clinical trial NCT02130011: Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose
Official title: Managing the Real Dose: Evaluating the Impact on Gastric Filling on the Delivered Radiation Dose in Gastrooesophageal Junction Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2014-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients in which the CTV was not covered
timeFrame: Weekly during radio-and chemotherapy (5 weeks)
Secondary outcomes:
measure: Thoracic margin evaluation
timeFrame: weekly during radio-and chemotherapy (5weeks)
measure: Stomach variation
timeFrame: Weekly during radio-and chemotherapy (5 weeks)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic
Study officials:
affiliation: Maastricht Radiation Oncology
name: Philippe Lambin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: