Combining acetazolamide with chemotherapy and radiotherapy for small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of acetazolamide, a carbonic anhydrase inhibitor, in combination with radiochemotherapy or radioimmunotherapy for patients with small cell lung cancer (SCLC). The approach is based on the over-expression of carbonic anhydrases in SCLC and the potential anti-tumor effects observed in preclinical studies. By targeting glucose metabolism and manipulating the tumor microenvironment, the study aims to enhance the effectiveness of standard treatments. This is the first clinical evaluation of acetazolamide in oncology, particularly in conjunction with radiotherapy and chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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

Where it's running

• Centre Antoine Lacassagne
  Nice, France Recruiting
• Centre Hospitalier Princesse grace
  Monte Carlo, Monaco Terminated

Study contacts

• Study coordinator: Jérôme DOYEN, PH
• Email: jerome.doyen@nice.unicancer.fr
• Phone: +33492031270

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.