Organ Motion and Early Tumor Response Measurement

Esophageal Cancer Clinical Trial

Official title:

Organ Motion and Early Tumor Response Measurement During Chemotherapy for Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139488
• Other study ID #: N13OME
• Status: Completed
• Start date: April 18, 2014
• Est. completion date: December 2018

Study information

• Verified date: June 2019
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To quantify motion based variation of the target volume of the primary tumor over the course of chemoradiotherapy in esophageal cancer patients, and to use this information to calculate appropriate PTV (planning target volume) margins according to the margins recipe for patients receiving trimodality (neoadjuvant chemoradiation and surgery) or definitive chemoradiation in order to personalize radiation treatment, resulting in either better target coverage or a reduction in normal tissue radiation exposure.

Description:

A single center prospective observational study will be performed in esophageal cancer patients. This study registers motion of the esophageal tumor, using 4D planning CT scans and repeated 4D CBCT scanning. Motion of fiducial markers inserted into the esophageal wall, will be used as a surrogate for tumor motion in the limited image quality of CBCT scans.

Patients planned for trimodality treatment will additionally be imaged by serial 4D Pet CT and MRI in week 0 (before start chemoradiotherapy), week 3 (during chemoradiotherapy) and week 10 (just prior to surgery) to observe (early) signs of tumor response.

Patients planned for definitive chemoradiation will not receive extra MRI imaging during treatment because of the inability to correlate this imaging with pathological response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologic evidence of invasive adenocarcinoma or squamous cell cancer of the esophagus

2. Patient eligible for trimodality treatment (chemoradiotherapy and surgery) or definitive chemoradiotherapy

3. T3N0M0 or T1-4N1-3M0. Patients with M1 disease solely on the basis of supraclavicular metastasis and not a junction tumor as primary are eligible. (AJCC 7th edition,).

4. WHO performance status =2 (WHO scale)

5. Clinically operable for R0 resection in the opinion of an experienced upper gastrointestinal or thoracic surgeon for patients planned for trimodality

6. Tumor localization at least 2cm from the upper esophageal sphincter and invading no more than 5cm into gastric cardia

7. Age = 18 years

8. Written informed consent before endoscopy or EUS

Exclusion criteria:

1. Prior treatment with thoracic surgery or thoracic radiotherapy

2. Pregnancy

3. Severe cardiopulmonary restriction

Related Conditions & MeSH terms

• Chemoradiation
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• Fiducial markers

• Fiducial markers, Pet and MRI
Insertion of Fiducial markers in esophageal wall.

Locations

Country	Name	City	State
Netherlands	The Netherlands cancer Institute	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify motion of the esophageal tumor over the course of chemoradiation	The outcome measures will be assessed by tracking the motion of the fiducial markers at the daily 4D CBCT (four dimensional cone beam CT scan). (primary outcome); By observing the motion of the fiducial, the exact setup error, breathing motion amplitudes, intra- and inter-fraction motion can be assessed.	6 weeks