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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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without feeding/fluid instructicon

Ten patients treated with preoperative chemoradiotherapy without feeding/fluid instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

with feeding/fluid instructions

Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions

Group Type EXPERIMENTAL

with feeding/fluid instruction

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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