Clinical trial · Interventional
Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
NCT02937948CI-TRIAL-00060677ARCOLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adaptative treatment plan | Other | — | UNRESOLVED |
| External radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adaptative Treatment plans
- description
- 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.
- interventionNames
- Other: Adaptative treatment plan
- Radiation: External radiotherapy
Primary outcomes (1)
- measure
- Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
- timeFrame
- 3 months after end of radio-chemotherapy treatment
Secondary outcomes (1)
- measure
- Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.