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Clinical Trials/NL-OMON31088
NL-OMON31088
Not yet recruiting
Phase 2

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

Antoni van Leeuwenhoek Ziekenhuis0 sites53 target enrollmentTBD
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Conditionsgastric cancerstomach cancer1001799010017991

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
gastric cancer
Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Enrollment
53
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Antoni van Leeuwenhoek Ziekenhuis

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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