Phase
Condition
Small Cell Lung Cancer
Treatment
acetazolamide in combination with platinum and etoposide-based radiochemotherapy
acetazolamide in combination with radioimmunotherapy in patients with extensive SCLC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age > or = 18 years,
Performance Status 0 to 2,
Patient with an histologically non-metastatic localized (or extensive SCLCsub-group) Small cell lung cancer,
Patient who must start radiotherapy treatment combined with chemotherapy withplatinum and etoposide (localized SCLC sub-group) or Patient who received 4 cyclesof chemoimmunotherapy with platinum salts, etoposide and immunotherapy (atezolizumabor durvalumab) as the first treatment (extensive SCLC sub-group) Note: The decisionof the Multidisciplinary Consultation Team must be notified in the patient's medicalfile,
Evaluation lesion according to the criteria RECIST 1.1 and / or according to thecriteria PERCIST 1.0,
Women of childbearing potential must have a negative serum pregnancy test within 72hours of the first administration of the study treatment,
If the patient is a woman of childbearing potential, she must be surgically sterileor agree to use two adequate methods of contraception throughout the duration of thestudy until 1 month after the last administration of the study treatment. Subjectsof childbearing potential are those who have not been surgically sterilized or havenot been free from menses for > 1 year, Note: Abstinence is acceptable if it is thepatient's usual and preferred form of contraception,
If the male patient has one or more female partners of childbearing age, he / shemust agree to use an adequate method of contraception, starting at the firstadministration of the study treatment up to 1 month after the last administration ofthe treatment. of the study, Note: Abstinence is acceptable if it is the patient'susual and preferred form of contraception,
Patient willing and able to provide written informed consent/assent for the trial,
Patient affiliated with a health insurance system.
Exclusion
Exclusion Criteria:
Patient with metastatic disease,
History of thoracic irradiation or near / in the thoracic irradiation field,
Patient who refuses to participate in the study or unable to agree,
Contraindication to thoracic radiotherapy treatment: congestive heart failureunbalanced (ejection fraction <30%, clinical signs), severe respiratory failure:
COPD grade IV according to the GOLD classification,
Some GOLD III COPD and any patient with a respiratory defect defined as: oxygendependence and / or FEV1 <40% normal and / or, DLCO <40% predictive value and /or vital capacity <40% predictive value,
Contraindication to acetazolamide: hypersensitivity to acetazolamide, severehepatic, renal or adrenal insufficiency, sulfonamide intolerance, history of renalcolic, allergy to wheat other than celiac disease,
Patient currently receiving one or more treatments described in section 6.9 of theprotocol,
History of cancer, with the exception of cancers in complete remission for more than 5 years, completely resected basal cell carcinoma of the skin or squamous cellcarcinoma of the skin that has undergone potentially curative therapy or in situcervical cancer,
People particularly vulnerable as defined in Articles L.1121-5 to -8 of the FrenchHealthcare Code, including: person deprived of freedom by an administrative orjudicial decision, adult being the object of a legal protection measure or outside astate to express their consent, pregnant or breastfeeding women
Study Design
Study Description
Connect with a study center
Centre Antoine Lacassagne
Nice, 06189
FranceActive - Recruiting
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