sequential fdg-pet (positron emission tomography) and induction chemotherapy in locally advanced adenocarcinoma of the esophagogastric junction (aeg)

Conditions: Adenocarcinomas of the Esophagogastric Junction

Summary: prospective, single-center, nonrandomized, explorative imaging study evaluating the value of pet as a predictor of histopathological response in metabolic non-responders patients with resectable aeg (adenocarcinoma of the esophagogastric junction) type i and ii (ct3/4 and/or cn+ and cm0) metabolic non-responders, showing a \<35% decrease of suv (standardized uptake value) two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based rct (radiochemotherapy) before surgery. 18fdg-pet scans will be performed before (=baseline) and after 14 days of standard neoadjuvant therapy as well after the first cycle of taxotere/cisplatin chemotherapy (=pet1) and at the end of intensified radiochemotherapy (pet2). tracer uptake will be assessed semiquantitatively using standardized uptake values (suv). the percentage difference delta suv=100(suvbaseline-suvpet1)/ suvbaseline will be calculated and assessed as an early predictor of histopathological response. in a secondary analysis, the association between the difference suvpet1 - suvpet2 and histopathological response will be evaluated.

the hicon trial is a prospective, single-center, nonrandomized, explorative imaging study evaluating the value of pet (positron emission tomography) as a predictor of histopathological response in metabolic non-responders patients with resectable aeg (adenocarcinoma of the esophagogastric junction) type i and ii, staged ct3/4 and/or cn+ and cm0 by endoscopic ultrasound, spiral ct or mri and fdg-pet are eligible. tumors must be potentially r0 resectable and must have a sufficient fdg-baseline uptake. only metabolic non-responders, showing a \<35% decrease of suv (standardized uptake value) two weeks after the start of neoadjuvant chemotherapy are eligible for the study and are taken to intensified taxane-based rct (chemoradiotherapy (45 gy) before surgery. 18fdg-pet scans will be performed before (=baseline) and after 14 days of standard neoadjuvant therapy as well after the first cycle of taxotere/cisplatin chemotherapy (=pet1) and at the end of intensified radiochemotherapy (pet2). tracer uptake will be assessed semiquantitatively using standardized uptake values (suv). the percentage difference delta suv=100(suvbaseline-suvpet1)/ suvbaseline will be calculated and assessed as an early predictor of histopathological response. in a secondary analysis, the association between the difference suvpet1 - suvpet2 and histopathological response will be evaluated..

Eligibility criteria:
inclusion criteria: * biopsy-proven adenocarcinoma of the distal oesophagus (aeg type i) or cardia (aeg type ii) with or without metastases in local lymph nodes (tumor stage ct3/t4, cnx, and cm0 in the tumor-node-metastasis classification) * staging procedures include endoscopy, endoscopic ultrasound and computed tomography (ct) of the chest and abdomen. * eligible patients have to be fit for platin-containing chemotherapy * tumors must be potentially r0 resectable tumors during consecutive operation. * tumors must have demonstrated a minimal amount of fdg-uptake in the baseline pet-ct, defined as 18fdg-uptake in tumor at first examination \> 1,35 x hepatic-suv + 2 x standard-deviation of hepatic-suv, and must be a metabolic non-responder under eox, defined as a decrease of the suvmax of \<35% in a second pet on day 14 of chemotherapy. exclusion criteria: * eastern cooperative oncology group score \>1 * previous or secondary malignancy * life expectancy of less than 3 months * uncontrolled bleeding from the tumor * tumor infiltration of the airways * pregnancy * uncontrolled diabetes * patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy.

Keywords: pet response evaluation neoadjuvant radiochemotherapy adenocarcinoma of the esophagogastric junction esophageal carcinoma evaluation of preoperative (radio)-chemotherapy in patients with adenocarcinomas of the oesophagogastric junction