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Clinical Trials/NCT02937948
NCT02937948CompletedNot Applicable

Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Center Eugene Marquis22 sites in 1 country85 target enrollmentStarted: April 5, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
85
Locations
22
Primary Endpoint
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Cervix carcinoma proved by histology
  • •According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
  • •Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
  • •Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
  • •Older than 18 years
  • •Good general status, World Health Organization less or equal to 1
  • •Signed informed consent

Exclusion Criteria

  • •History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
  • •History of pelvic irradiation
  • •Simultaneous participation to another research that could interfere with the study results
  • •Pregnant or breastfeeding patient
  • •Patient under tutor or guardian
  • •Patient not able to respect medical follow-up for geographical, social or psychological reasons
  • •Not affiliated to a system of French social security

Outcomes

Primary Outcomes

Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03

Time Frame: 3 months after end of radio-chemotherapy treatment

Secondary Outcomes

  • Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03(3 months after end of radio-chemotherapy treatment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (22)

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