Status:
RECRUITING
Phase I Trial of CArbonic Anhydrase Inhibition in Combination with Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy or radioimmunotherapy in small cell lung cancer due to: 1. The over-...
Detailed Description
Compared with healthy cells, glucose metabolism is greatly modified in cancer cells because of their highly proliferative character. This differential tumor / healthy tissue property is an opportunity...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 27 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03467360
Start Date
August 2 2019
End Date
April 27 2027
Last Update
January 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Antoine Lacassagne
Nice, France, 06189