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Completed

NCT Number: NCT02130011

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

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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Key information

Conditions

Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MAASTRO clinic

Maastricht, 6229 ET, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

with feeding/fluid instruction

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

Primary outcomes

  1. Proportion of patients in which the CTV was not covered

    Time frame: 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 outcomes

  1. Thoracic margin evaluation

    Time frame: 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

  2. Stomach variation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Maastricht University Medical Center

Registry information

Official study title

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

Acronym: DGRT

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
May 2, 2014
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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