eoadjuvant chemoradiation for patients with adenocarcinoma of the stomach. A feasibility and efficacy study.

Phase 2

Completed

• Conditions: gastric cancer; 10017990; 10017991

• Registration Number: NL-OMON33628
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- Histologically proven and documented adenocarcinoma of the stomach
- Surgical resectable gastric cancer stage IB-IVA: T1N1; T2-4, N0-1, M0 ( see appendix), as determined by Endoscopic Ultra Sound (EUS), Computed Tomography (CT).
- Age >= 18 and <= 75
- Ambulatory performance status (WHO scale 0 - 2; see appendix)
- No prior chemotherapy
- No prior radiotherapy
- If the tumor extends above the gastroesophageal (GE) junction into the esophagus, the bulk of the tumor(therefore more than 50%)must involve the stomach. The tumor must not extend more than 2 cm into esophagus.
- Adequate hematological, renal and hepatic functions defined as:
- White blood cell count >= 4.0 x 109/L
- Platelet count >= 100 x 109/L
- Serum bilirubin <= 1.5 x upper normal limit
- Calculated Creatinine Clearance >=50 ml/min (cockcroft formula)
-Two equally functioning kidneys determined with standard technology (renogram)
- Tumor negative laparoscopy when CT suggests peritoneal carcinomatosis
- Written, voluntary informed consent (interval between information and consent at least 7 days)
- Patients must be accessible to follow up and management in the treatment center
- Patients must sufficiently understand the Dutch language and must be able to sign the informed consent document.

Exclusion Criteria

- T1N0 tumors and in situ carcinoma (endoscopic ultrasound) are not eligible
- Distant metastases
- In case of only one functional kidney
- Previous or current malignancies at other sites than entry diagnosis except for adequately treated basal or squamous cell carcinoma of the skin, or curatively treated carcinoma in situ of the cervix uteri
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy, or prior esophageal or gastric surgery.
- Evidence of serious active infections
- Severe cardiac and/or pulmonary failure, uncontrolled hypertension, angina pectoris
- Clinical signs of myocardial ischaemia
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Pregnant or lactating women. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the possible delay in performing a curative resection<br /><br>due to increased toxicity of more than 10% with a stopping point at a delay in<br /><br>six patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are :<br /><br>- efficacy<br /><br>- occurence of downstaging and changes in pathology</p><br>