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

Primary Purpose

Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
with feeding/fluid instruction
Sponsored by
Maastricht Radiation Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • MAASTRO clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

without feeding/fluid instructicon

with feeding/fluid instructions

Arm Description

Ten patients treated with preoperative chemoradiotherapy without feeding/fluid instructions

Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions

Outcomes

Primary Outcome Measures

Proportion of patients in which the CTV was not covered
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

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

Full Information

First Posted
March 13, 2014
Last Updated
October 5, 2015
Sponsor
Maastricht Radiation Oncology
Collaborators
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02130011
Brief Title
Dose-Guided Radiotherapy in Oesophageal Cancer: Managing the Real Dose
Acronym
DGRT
Official Title
Managing the Real Dose: Evaluating the Impact on Gastric Filling on the Delivered Radiation Dose in Gastrooesophageal Junction Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht Radiation Oncology
Collaborators
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
without feeding/fluid instructicon
Arm Type
No Intervention
Arm Description
Ten patients treated with preoperative chemoradiotherapy without feeding/fluid instructions
Arm Title
with feeding/fluid instructions
Arm Type
Experimental
Arm Description
Ten patients treated with preoperative chemoradiotherapy with feeding/fluid instructions
Intervention Type
Other
Intervention Name(s)
with feeding/fluid instruction
Intervention Description
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 Outcome Measure Information:
Title
Proportion of patients in which the CTV was not covered
Description
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
Time Frame
Weekly during radio-and chemotherapy (5 weeks)
Secondary Outcome Measure Information:
Title
Thoracic margin evaluation
Description
evaluation if a CTV-PTV margin of 5 mm in the thoracic part of the target volume is sufficient
Time Frame
weekly during radio-and chemotherapy (5weeks)
Title
Stomach variation
Description
stomach movement evaluation on a weekly cone beam CT during chemo radiotherapy with and without feeding/fluid instructions.
Time Frame
Weekly during radio-and chemotherapy (5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Lambin, MD, PhD
Organizational Affiliation
Maastricht Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAASTRO clinic
City
Maastricht
ZIP/Postal Code
6229 ET
Country
Netherlands

12. IPD Sharing Statement

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

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