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Sparing of Organs at Risk in High Dose Rate Brachytherapy

24. juli 2013 oppdatert av: Centre Oscar Lambret

Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer

Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.

In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.

The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.

This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.

Studieoversikt

Status

Fullført

Forhold

Cervical Carcinoma Stage IB to IV

Detaljert beskrivelse

After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions.

A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.

During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Frankrike
- - Lille, Frankrike, 59020
    - Centre Oscar Lambret

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II.

After realization of external radiation therapy done (60 Gy in IMRT)

Beskrivelse

Inclusion Criteria:

Cervix carcinoma stage Ib to IV (FIGO)
OMS < 2
Tomography by positron emission and/or chirurgical staging before the external radiotherapy
RMN before the starting of treatment and at the end af external radiotherapy
Patient information
Validation of the indication af high dose rate brachytherapy
External radiation therapy (60 Gy with IMRT)

Exclusion Criteria:

No external radiation therapy
Surgery in the 4 weeks before before the inclusion
Prior pelvic radiation therapy
intestinal inflammatory disease or active pathology
active infection or severe pathology didn't allow the treatment
Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)
Inclusion in another clinical trial

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification Tidsramme: At 8 weeks of external radiotherapy	To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.	At 8 weeks of external radiotherapy

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Evaluation of medical imaging with CT-Scan and RMN for cervix cancer Tidsramme: At 8 weeks of external radiotherapy	Interest of RMN sequences Water and T2 for the definition of volumes Evaluation of imaging registration on the planning treatment system based on the brachytherapy applicator for the precision of volumes delineation Evaluate the interest of TDM and RMN for volumes delineation	At 8 weeks of external radiotherapy

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Oscar Lambret

Etterforskere

Studieleder: Philippe Nickers, MD, PhD, Centre Oscar Lambret

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

1. februar 2013

Studiet fullført (Faktiske)