EUCTR2005-006097-10-DE
Active, not recruiting
Not Applicable
Pilot study of dose-escalated radiotherapy with PET/CT based treatment planning in combination with induction and concurrent chemotherapy in locally advanced (uT3/T4) squamous cell cancer of the esophagus - SPOT
niversitätsklinikum Essen0 sites41 target enrollmentMarch 2, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Phase II study of dose-intensified radiation therapy based on PET/CT-Planning in combination with induction- and concurrent chemotherapy in locally advanced squamous cell carcinomas (uT3/T4) of the esophagus
- Sponsor
- niversitätsklinikum Essen
- Enrollment
- 41
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •·Patients with histologic confirmed squamous cell carcinoma of the upper and mid third of the esophagus; e.g. tumors with a proximal edge within 35 cm behind the teeth and a distant edge at least 3 cm above the anatomic cardia, length of the tumor not more than 10 cm
- •·Tumor stage uT3\-T4 NX M0 (based on endoscopic ultrasound and PET\-CT)
- •·Age between 18\-70 years
- •·Performance status WHO grade 0 to 2
- •·Normal liver\-, renal\- and bone marrow function (serum\-bilirubin \< 1,5 mg/dl, PTT \> 70%, total protein \> 60 g/l, cholinesterase \> 3000 U/l, creatinine \< 1,3 mg/dl or creatinin\-clearance \> 60 ml/min, leukocytes \> 4000/ml, thrombocytes \> 150\.000/ml, hemoglobin \> 10 g/dl)
- •·Planned dose of radiotherapy is within the tolerance dose of organs at risk according to computer\-planning based on initial PET/CT
- •·Sufficient capacity of heart and lung (as defined in the protocol)
- •·Written informed consent based on complete patient information
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •·Previous chemotherapy, radiotherapy or surgery (regarding the esophagus or the stomach)
- •·Metastatic disease (including Lymph node metastases beyond regional lymph nodes (see UICC\-classifikation 2003\)
- •·Esophago\-tracheal / bronchial fistula
- •·Contraindications against the use of cisplatin, 5\-FU/folinic acid or irinotecan
- •·Uncontrolled infection
- •·Current abuse of alcohol or other drugs
- •·Women of child\-bearing potential with unclear contraception
- •·Pregnancy or lactation
Outcomes
Primary Outcomes
Not specified
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