esophageal cancer foregut cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In what proportion of patients with a locoregional recurrence, observed at 6, 12 or 18 months after treatment, can the locoregional recurrence be considered a possibly preventable recurrence if PET/CT-based treatment planning was used instead of CT-based treatment planning alone? | — |
Secondary
| Measure | Time frame |
|---|---|
| - What is the interobserver variability of defined GTV, CTV and PTV? - What is the size of GTV, CTV and PTV for CT-based and PET/CT-based treatment planning? - How is the dose distribution in risk organs, including lung (Mean lung dose, V20), heart (V30) and calculation of NTCP values (Normal Tissue Complication Probability) comparing 3D-CRT and IMRT and IGRT with and without PET/CT-based treatment planning? - What is the disease free survival at 6 and 12 months both for the entire group and for the subgroups based on recurrence localisation inside or outside the CT-based CTV? - What are the costs of radiotherapy planning and treatment (surgical and/or chemoradiation), complications and recurrence-related treatment or the prevention thereof? - How many patients develop distant metastases after treatment? | — |
Countries
Netherlands
Outcome results
None listed