Immediate tumor resection in patients with locally advanced gastroesophageal adenocarcinoma with nonresponse to chemotherapy after 4 weeks of treatment versus resection after completion of chemotherapy - A randomized controlled pilottrial (Optitreat)

Immediate tumor resection in patients with locally advanced gastroesophageal adenocarcinoma with nonresponse to chemotherapy after 4 weeks of treatment versus resection after completion of chemotherapy - A randomized controlled pilottrial (Optitreat) - OPTITREAT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004668

Enrollment

120

Registered

2013-07-24

Start date

2014-09-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15 C16

Interventions

Group 1: Patients with esophagogastric adenocarcinoma Endoscopy and endoscopic ultrasound after 4 weeks of chemotherapy. Randomization of nonresponder (no major reduction of tumor size). Arm 1: Stop o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • histologically proven adenocarcinoma of the esophagus or stomach • clinical staging cT3/4 and/or cN+ • Resectable primary tumor • Patient considered to tolerate surgery including abdominothoracic resection (Karnofsky >80%) • = 18 years of age • Written informed consent

Exclusion criteria

Exclusion criteria: • Lack of understanding or language problems • expected lack of compliance • Patients not eligible for surgery (ASA = IV) • distant metastases (M1) without possibility of complete resection (R0) • neoadjuvant radiochemotherapy

Design outcomes

Primary

Measure	Time frame
R0 resection rate (pathological report, after surgery)	—

Secondary

Measure	Time frame
Overall survival (Follow-up by phone: every 3 months during the first year, every 6 months during the second year and once a year or until death) perioperative morbidity and mortality (clinical report after demission) Quality of life (questionnaire, screening visit, before operation, 12 months after surgery) Cost savings (after termination of therapy)	—

Countries

Germany

Contacts

Public ContactSusanne Blank

Universitätsklinikum Heidelberg Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

susanne.blank@med.uni-heidelberg062216535758

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026