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Completed

NCT Number: NCT02937948

Adaptative Radiotherapy for Locally Advanced Cervical Cancer

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.

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Key information

Conditions

Uterine Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptative treatment plan

Other

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.

External radiotherapy

Radiation

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.

Primary outcomes

  1. 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

  1. Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03

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

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Acronym: ARCOL

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Oct 19, 2016
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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