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
Conditions
Interventions
Product Name: CALCIUMFOLINAT-biosyn liquid
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Calciumfolinat-Pentahydrat
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion 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 70%, total protein > 60 g/l, cholinesterase > 3000 U/l, creatinine 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of local tumor control (local progression-free survival) at 1 year in locally advanced esophageal cancer;Secondary Objective: Determination of the ·Rate of tumor remission after induction chemotherapy ·Rate of complete tumor remission at the end of treatment ·Rate of treatment related mortality ·Overall survival at 2 years ·Rate of distant metasases ·Acute and chronic toxicity;Primary end point(s): survival without local tumor progression at 1 year after start of treatment | — |
Countries
Germany
Outcome results
None listed