Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Center Eugene Marquis
- Enrollment
- 85
- Locations
- 12
- Primary Endpoint
- Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
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
Arms & Interventions
Adaptative Treatment plans
A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day.
Intervention: Adaptative treatment plan (Other)
Adaptative Treatment plans
A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day.
Intervention: External radiotherapy (Radiation)
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)