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SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

* Prospective, open-label, bi-center study, assessing the clinical outcomes of adaptive breast radiotherapy with ETHOS in hypersensitive patients. * Bi-centric with ETHOS center : ICM (Institut du Cancer de Montpellier) and ISC (Institut Sainte Catherine) Avignon * 500 patients will be included: * COHORTE A = Treatment ETHOS RT :46 evaluable patients with high risk of LRR and bf+ risk * COHORT B = Conventional IMRT : 454 others patients with high risk of LRR and bf- risk

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women ≥ 18 years old.

Conservative breast cancer surgery or radical mastectomy.

At least pN1 breast cancers, regardless breast cancer subtypes.

Tumor negative margins.

Disqualifiers

Patients with distant metastases.

Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast.

Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years.

Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment ETHOS radiotherapy

    Radiation

    • Cohort A: Adaptive RT: PTV = CTV + 2 mm (except for IMC with 5mm), excluding 5mm beneath the skin

  • Conventional IMRT

    Radiation

    • Cohort B: IMRT: PTV = CTV + 7mm, excluding 5mm beneath the skin

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Cohort A : Experimental groupExperimental treatment 1 intervention
Group B: Cohort B : Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of patients without any grade 2 and more toxicities within the planning target volume

A toxicity of grade 2 and more is defined as an observation of grade 2 and more, in case of late toxicities it should be at least confirmed by two consecutive visits.

Time frame
at 3 years

Secondary outcomes

1

rate of Acute & late toxicity

acute toxicity is defined as side effects observed from the start of RT to 12 weeks post RT, according to NCI-CTCAE v5. Late toxicity is defined as side effects observed from 12 weeks post RT to 3 years post RT, according to NCI-CTCAE v5

Time frame
From the start of RT to 12 weeks post RT and from 12 weeks post RT to 3 years post RT
2

Quality of life by using QLQ-C30 (and BR 23 module) questionnaire score

score obtained by assessed questionnaires

Time frame
at 0/3/6/12/18/24/30/36 months post RT
3

Quality of life by using GPAQ questionnaire score

score obtained by assessed questionnaires

Time frame
at 0/3/6/12/18/24/30/36 months post RT
4

Quality of life by using MFI questionnaire score

score obtained by assessed questionnaires

Time frame
at 0/3/6/12/18/24/30/36 months post RT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut du Cancer de Montpellier - Val d'Aurelle

Lead sponsor

Source ClinicalTrials.gov
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