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NCT05794035Toboroz

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients

Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. nov. 30. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR). Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors. In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction. In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL. the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
303 (tervezett)
Első benyújtás
2023. febr. 15.
Kezdés
2023. okt. 17.
Elsődleges befejezés
2028. márc. 1.
Fő szponzor
Assistance Publique - Hôpitaux de Paris
Betegségek
Melanóma
NCT-szám
NCT05794035

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 303
  • 2023. okt. 17. és az elsődleges befejezés (2028. márc. 1.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Macroscopic incomplete resection of the primary tumor (≥ R1)

Más betegség

  • Patient with severe dementia not allowing follow-up
  • Other active cancers in treatment

Egyéb

  • Any psychological, familial, sociological, geographical or logistical reasons that would prevent participation to surveillance during treatment and follow-up
  • Participation in another interventional study (therapeutic trial interfering with the study's endpoints)
  • Patient on AME (state medical aid)
  • Persons deprived of their liberty by a judicial or administrative decision

Kiket keres a vizsgálat

  • Patients aged ≥ 70 years
  • OMS 0-3
  • Pathology confirmation of invasive SCC or BCC
  • At least one of high-risk factors for recurrence (R0 but close margins, location/size, microscopic perineural invasion, recurrent primary disease, immunosuppression, thickness including Breslow and Clark level, poorly-moderately differentiated)
  • No indication of regional nodal RT
  • No prior RT to the treated site
  • Written consent from patient or his/her legal representative, trustworthy person or family member if the person is physically unable to give his or her written consent
  • Life expectancy ≥ 6 months, as clinically estimated by the investigator in charge of enrolment
  • No contraindication for surgery and RT after multidisciplinary board meeting evaluation
  • Affiliated to a social security scheme

Életkor a regiszterben: 70 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Henri MondorCréteilFranciaországToboroz

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