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Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose (DGRT)

M

Maastricht Radiation Oncology

Status

Completed

Conditions

Adenocarcinoma

Treatments

Other: with feeding/fluid instruction

Study type

Interventional

Funder types

Other

Identifiers

NCT02130011
14-01-15/01-intern-6505 (Other Identifier)
DGRT

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

without feeding/fluid instructicon
No Intervention group
Description:
Ten patients treated with preoperative chemoradiotherapy without feeding/fluid instructions
with feeding/fluid instructions
Experimental group
Description:
Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions
Treatment:
Other: with feeding/fluid instruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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