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Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02937948
Acronym
ARCOL
Enrollment
85
Registered
2016-10-19
Start date
2017-04-05
Completion date
2022-04-11
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Cancer

Keywords

Locally advanced

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.

Interventions

OTHERAdaptative treatment plan

Each patient will have 3 scanners before treatment initiation. One corresponding to an empty bladder, one to an intermediate one, one to a full bladder.

At the time of each fraction of external radiotherapy, the most appropriate plan (empty, intermediate, full bladder) covering the target and sparing the organs at risk is chosen.

Sponsors

Center Eugene Marquis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.033 months after end of radio-chemotherapy treatment

Secondary

MeasureTime frame
Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.033 months after end of radio-chemotherapy treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026