EO-ADJUVANT RADIOTHERAPY-CHEMOTHERAPY IN STOMACH CANCER Induction therapy with carboplatin, paclitaxel and radiotherapy in patients with locally advanced gastric cancer

Phase 2

Conditions: gastric cancer
stomach cancer
10017990
10017991

Registration Number: NL-OMON31088

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 53

Inclusion Criteria

• T4 tumors (extension into the esophagus is acceptable as long as the bulk (>50%) of the tumor is in the stomach), and/or N2 nodes > 7 suspected nodes on EUS or CT scan, and/or one large lymph node (mass or conglomerate), and/or > 3 suspected lymph nodes in truncus / para-aortal / spleen hilus. All lymphnodes have to be in cranial position of the renal arteries (in other words tumors that are not suitable for participation in the CRITICS (M06CRI) study)
* stage Ib-IVa (no distant metastases) gastric cancer (histologically confirmed); tumor bulk has to in the stomach but may involve the gastro-esophageal junction
• WHO <= 2
* age 18-70
* gastric cancer should be operable according to one of the coordinating surgeons
* tumornegative laparoscopy
* no prior RT abdomen and/or chemotherapy
• Hematology: Hb>6.5 mmol/l; leukocytes>3.5x109/l, neutrophils > 1.5x109/l, thrombocytes > 100 x 109/l
• Renal function: serum creatinine <= 1.25 ULN and creatinine clearance > 60 ml/min (measured, or calculated by Cockcroft and Gault formula)
• Liver function: total bilirubin <1.5x ULN, Alk.phosph. and ASAT/ALAT <= 3x ULN
• Registration within 20 working days after gastroscopy
• Start treatment within 10 working days after registration
• Written informed consent

Exclusion Criteria

• Distant metastasis; i.e. lymph node metastasis that are encompassed in the radiation portals are acceptable
• Suspected lymph nodes below the renal arteries
• Inoperable patients; due to technical surgery-related aspects or general condition (ASA III or IV)
• Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri. In case of other malignancies, the patients has to be disease-free for * 5 years to be eligible
• Previous radiotherapy involving the planned treatment field or compromising bone marrow reserve
• Previous chemotherapy except adjuvant chemotherapy for e.g. breast or coloncarcinoma, if * 5 years before
• Uncontrolled (bacterial) infections
• Significant non-malignant disease which in the opinion of the study coordinators is incompatible with the protocol
• Neurotoxicity > CTC grade 1
• Pregnancy or breast feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy (resectability rate, pCR rate, R0 rate) and safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Disease free survival and overall survival<br /><br>• To investigate if PET (positron emission tomography) imaging before, during<br /><br>and after chemoradiotherapy can predict pathological response<br /><br>• Collect tissue and serum before chemoradiotherapy for genomic profiling and<br /><br>proteomics to detect tumor recurrence risk patterns in gastric cancer</p><br>