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

Conditions: esophageal cancer
foregut cancer
10017991

Registration Number: NL-OMON32449

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- histological documented cancer of the esophagus or gastroesophageal junction (GEJ)
- locally curable disease without distant metastases (M1b is 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
- no serious medical/psychiatric illness
- 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.
- patients are required to have an adequate total caloric intake to allow them to maintain their body weight (stable weight or less than 2 pound weight loss) for at least one week prior to registration

Exclusion Criteria

- patients with known distant metastases
- previous or concurrent malignancy (except for basal cell carc of the skin or in situ ca. of the cervix or superficial bladder ca (pTa) in the past five years.
- prior chest or upper abdomen 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, can the locoregional recurrence be considered<br /><br>a possibly preventable recurrence if PET/CT-based treatment planning was used<br /><br>instead of CT-based treatment planning alone?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- What is the interobserver variability of defined GTV, CTV and PTV?<br /><br>- What is the size of GTV, CTV and PTV for CT-based and PET/CT-based treatment<br /><br>planning?<br /><br>- How is the dose distribution in risk organs, including lung (Mean lung dose,<br /><br>V20), heart (V30) and<br /><br>calculation of NTCP values (Normal Tissue Complication Probability) comparing<br /><br>3D-CRT and IMRT and<br /><br>IGRT with and without PET/CT-based treatment planning?<br /><br>- What is the disease free survival at 6 and 12 months both for the entire<br /><br>group and for the subgroups<br /><br>based on recurrence localisation inside or outside the CT-based CTV?<br /><br>- What are the costs of radiotherapy planning and treatment (surgical and/or<br /><br>chemoradiation),<br /><br>complications and recurrence-related treatment or the prevention thereof?<br /><br>- How many patients develop distant metastases after treatment?</p><br>