Value of PET-CT in Radiation Treatment Planning for Patients with Esophageal Cancer (RESPECT-shadow-study)

• Conditions: esophageal cancer; foregut cancer; 10017991

• Registration Number: NL-OMON33678
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

-histological documented cancer of the esophagus or gastroesophageale junction (GEJ)
- locally curable disease without distant metastases (M1b excluded)
planned for high dose radiotherapy with or without chemotherapy
- no previous or concurrent malignancy (except for basal cell ca. of the skin or in situ ca. of the cervix or superficial bladder ca. (pTa) in the past five years.
- previously untreated patients (except induction chemotherapy)
- no evidence of serious active infections
- age >= 18 years
- written informed consent to participate in the study
- patients must have an WHO performance status 0-2
- all patients must be evaluated by a radiation oncologist prior to enrollment to ensure that the patient is an appropriate candidate for radiation therapy.

Exclusion Criteria

- known distant metastases
- previous or concurrent malignancy (except for basal cell ca. of the skin or in situ ca. of the cervix or superficial bladder ca. (pTa) in the past five years
- prior chest or upper abdominal radiotherapy, prior systemic chemotherapy, or prior esophageal or gastric surgery.
- evidence of serious active infections
- dementia or altered mental status that would prohibit the understanding and giving of informed consent
-pregnant or lactating women. sexually active patients of childbearing potential must implement effective contraceptive practices during the study while in this study

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In what proportion of patients with a locoregional recurrence, observed at 6,<br /><br>12 or 18 months after treatment, do recurrences occur outside the PET/CT-based<br /><br>CTV and can be considered as unpreventable?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>