A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer
NCT ID: NCT00590278
Last Updated: 2008-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2002-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Tomudex
Radiotherapy
Haematology
Biochemistry
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* At least 1 measurable lesion should be present
* WHO performance score \< 2
* Life expentancy of at least 12 weeks
* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
* Documented informed consent to participate in the trial
Exclusion Criteria
* Previous radiotherapy to the planned exposure area
* Subjects with distant metastases
* (a)white blood cell \< 4.0x109/L (unless absolute neutrophil count is \>2.0x109/L or (b) Platelet count \< 100x109/L
* Serum creatinine above the upper limit of the normal range
* (a) Serum bilirubin \> 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) \>2.5 times the upper limit of the normal range
* Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
* Pregnancy or breast feeding. Women of childbearing age must use effective contraception
* Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
* Patient participation in other studies
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Turkey Clinical Study Information
Principal Investigators
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Tayfun Hancilar, MD
Role: PRINCIPAL_INVESTIGATOR
Okmeydani Hospital Istanbul
Locations
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Research Site
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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1694TR/01
Identifier Type: -
Identifier Source: org_study_id
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