Trial · NCT03467360
Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma
NCT03467360, Phase 1, Recruiting, Centre Antoine Lacassagne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma. Trials, record NCT03467360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03467360
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma
- NCT number
- NCT03467360
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 27 participants, estimated
- Lead sponsor
- Centre Antoine Lacassagne
- Conditions
- Small Cell Lung Cancer
- Interventions
- acetazolamide in combination with platinum and etoposide-based radiochemotherapy, acetazolamide in combination with radioimmunotherapy in patients with extensive SCLC
- First posted
- 2018-03-16
- Last updated
- 2026-01-20
- Other registries' IDs
- eudract:2017-002160-40
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To identify the Tolerated Maximum Dose (DMT) and Recommended Dose (DR) of acetazolamide in combination with radiotherapy combined with platinum and etoposide chemotherapy (localized SCLC) or with radioimmunotherapy (extensive SCLC) | 8 months | The frequency of limiting dose toxicities determined by the number of Adverse Events as Assessed by CTCAE v4.03 : * during the 6 weeks of treatment with acetazolamide / chemoradiation based on platinum and etoposide and in the first 6 months of follow-up after the last administration of the treatment * during the 10 days of treatment with acetazolamide / radioimmunotherapy and in the first 6 months after the last administration of the treatment with radioimmunotherapy, for the "extensive SCLC" subgroup |
| Secondary | To determine the overall tolerance of the association acetazolamide and radiochemotherapy (localized SCLC) or of the association acetazolamide and radioimmunotherapy (extensive)SCLC) | 27 months | The overall tolerability of the treatments will be measured by clinical (performance status), laboratory (blood sample), and paraclinical evaluations (ETT, EFR) and defined on the NCI CTCAE V4.03 scale |
| Secondary | To evaluate the effectiveness of the treatment | 24 months | The tumor response (complete or partial, stabilization, progression) will be performed by Morphological evaluations using a scanner according to RECIST 1.1 criteria |
| Secondary | To evaluate the effectiveness of the treatment | 24 months | The tumor response (complete or partial, stabilization, progression) will be performed by Metabolic evaluations using a PET-CT scan according to the criteria PERCIST 1.0 |
| Secondary | To identify predictive factors for response to acetazolamide | 3 months | The evaluation of predictive factors of acetazolamide response will be determined by serum CAIX and CAXII levels (in the 7 days before the start of acetazolamide and the end-of-treatment visit) |
| Secondary | To identify predictive factors for response to acetazolamide | 30 months | The evaluation of predictive factors of acetazolamide response will be determined by: o The initial 18-FDG PET-CT scan (SUVmax, SULpeak) fixation intensity and 3 months after treatment, |
| Secondary | To evaluate progression-free survival at 24 months | 24 months | To determine the delay between the date of inclusion and the date of progression or death |
| Secondary | To evaluate overall survival at 24 months | 24 months | To determine the delay between the date of inclusion and the date of death |
| Secondary | To determine the compliance of acetazolamide | 27 months | Compliance assessment will be done using Girerd's questionnaire |
| Secondary | To evaluate the quality of life | 27 months | Quality of life will be determined using EORTC QLQC30 questionnaire |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03467360
GET https://conductscience.org/api/trials/v1/NCT03467360/registered