Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma

Korábbi kezelés

• Patient currently receiving one or more treatments described in section 6.9 of the protocol,

Más betegség

• Patient with metastatic disease,
• History of thoracic irradiation or near / in the thoracic irradiation field,
• Contraindication to acetazolamide: hypersensitivity to acetazolamide, severe hepatic, renal or adrenal insufficiency, sulfonamide intolerance, history of renal colic, allergy to wheat other than celiac disease,
• 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 cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer,

Laborértékek

• Contraindication to thoracic radiotherapy treatment: congestive heart failure unbalanced (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: oxygen dependence and / or FEV1 \<40% normal and / or, DLCO \<40% predictive value and / or vital capacity \<40% predictive value,

Egyéb

• Patient who refuses to participate in the study or unable to agree,
• People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women

• Age \> or = 18 years,
• Performance Status 0 to 2,
• Patient with an histologically non-metastatic localized (or extensive SCLC sub-group) Small cell lung cancer,
• Patient who must start radiotherapy treatment combined with chemotherapy with platinum and etoposide (localized SCLC sub-group) or Patient who received 4 cycles of chemoimmunotherapy with platinum salts, etoposide and immunotherapy (atezolizumab or durvalumab) as the first treatment (extensive SCLC sub-group) Note: The decision of the Multidisciplinary Consultation Team must be notified in the patient's medical file,
• Evaluation lesion according to the criteria RECIST 1.1 and / or according to the criteria PERCIST 1.0,
• Women of childbearing potential must have a negative serum pregnancy test within 72 hours of the first administration of the study treatment,
• If the patient is a woman of childbearing potential, she must be surgically sterile or agree to use two adequate methods of contraception throughout the duration of the study until 1 month after the last administration of the study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year, Note: Abstinence is acceptable if it is the patient's usual and preferred form of contraception,
• If the male patient has one or more female partners of childbearing age, he / she must agree to use an adequate method of contraception, starting at the first administration of the study treatment up to 1 month after the last administration of the treatment. of the study, Note: Abstinence is acceptable if it is the patient's usual 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.