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Clinical Trials/JPRN-jRCTs021190022
JPRN-jRCTs021190022
Recruiting
Phase 2

Prospective study about the safety of radiotherapy for gynecologic tumors using ethyl ester of iodinated poppy-seed oil fatty acid - The study of radiotherapy for gynecological tumors using lipiodol

mezawa Rei0 sites50 target enrollmentFebruary 20, 2020
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ConditionsCervical cancer, Vaginal cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cervical cancer, Vaginal cancer
Sponsor
mezawa Rei
Enrollment
50
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 20, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
mezawa Rei

Eligibility Criteria

Inclusion Criteria

  • •(1\) Cervical cancer, Vaginal cancer
  • •(2\) Patients with indications for definitive radiotherapy
  • •(3\) Age between 20 and 80 years old
  • •(4\) ECOG performance status 0\-2
  • •(5\) No prior abdominopelvic irradiation
  • •(6\) It is possible to stop taking or do not intake any anticoagulant or antiplatelet
  • •(7\) Patients with sufficient organ function
  • •\- neutrophil count greater than 2,000/mm3
  • •\- hemoglobin greater than 8g/dL
  • •\- platelets greater than 50,000/mm3

Exclusion Criteria

  • •(1\) Severe comorbidities (such as heart failure, renal failure, hepatic failure, respiratory dysfunction, lymph duct obstruction, poorly controlled diabetes and poorly controlled hypertension)
  • •(2\) Active thyroid disease
  • •(3\) Pyrexia of 38 degrees centigrade or higher.
  • •(4\) An allergy to iodine drugs
  • •(5\) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
  • •(6\) Psychiatric comorbidities or problems hinders enrollment of the study
  • •(7\) Attending physician believes the patient is not suitable for the study

Outcomes

Primary Outcomes

Not specified

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