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| ID | Type | Description | Link |
|---|---|---|---|
| GFPC 01-2013 | Other Identifier | GFPC |
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The purpose of this study was to determine prospectively in all patients with SCLC in second line therapy that progression-free survival with the expected reintroduction of platinum / etoposide is greater progression-free survival in the standard arm (topotecan ) in patients who have relapsed at least three months after initial chemotherapy with platinum-etoposide
Topotecan is currently the only drug approved in Europe and the United States for the treatment of second line of SCLC when the recovery first line of treatment is considered inappropriate. This raises the problem of knowing when the recovery first line of treatment should be considered appropriate. Secondly, the effectiveness of response to chemotherapy can be predicted based on the response to initial chemotherapy and the time interval after stopping first line treatment. A complete response after initial treatment and a long disease-free interval are predictors of better response to a second-line treatment. There are two groups: the said patients 'sensitive', which correspond to the first-line chemotherapy and who have relapsed at least 90 days after the first-line treatment and a group of so-called patients "Refractory" refers patients who progress in 90 days or patients who have not responded or progressed during first-line treatment. Median survival is very different depending on whether patients with so-called "sensitive" or "refractory".
When relapse occurs six months after the end of the first line chemotherapy, the usual practice is to reintroduce the first-line treatment. This is based on old studies where the number of patients included was low. If the interval of time after the first line of treatment is ≥ three months, two second-line treatment strategies are possible resumption of initial chemotherapy or topotecan. The combination of cisplatin with etoposide have shown high response rate, whatever the time of relapse. There are, however, no randomized study in the literature comparing topotecan to the reintroduction of a platinum salt associated etoposide.
This study is Randomized, multicenter, controlled, open-label, second line, 2 arms.
Arm A : Carboplatin Auc 5 J1 Etoposide 100 mg / m² / J J1 to J3 IV Arm B : topotecan 2.3 mg / m²J1 to J5 po
1 line by Etoposide Cisplatin or carboplatin etoposide Time interval between the first-line chemotherapy and relapse ≥ 90 days (the date is set at J1 of the last cycle) J-28: TDM thoracoabdominal, brain CT or MRI brain, J 7: Biology, quality of life questionnaire (Lung Cancer Symptom Scale). Assessment of tumor response every 6 weeks during chemotherapy post-chemotherapy followed 2nd line: TDM every 8 weeks until progression or death.
The duration of the participation of each patient included in the trial will be from inclusion through 12 months.
The planned total duration of the trial will be 5 years including 4 years of patient inclusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : Carboplatin-Etoposide | Experimental | Intravenous administration of Carboplatin Auc 5 at Day 1 and Intravenous administration of 100 mg / m² / of Etoposide J Day 1 to Day 3 The CT scans evaluations will be conducted during chemotherapy every 6 weeks |
|
| Arm B : Topotecan | Active Comparator | Per os administration of 2.3 mg / m² of Topotecan Day 1 to Day 5 The CT scans evaluations will be conducted during chemotherapy every 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Intravenous administration of Carboplatin AUC 5 at Day 1, Every 3 weeks, maximum 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Benefit in terms of progression-free survival of a therapeutic strategy | Determine the benefit in terms of progression-free survival of a therapeutic strategy by second-line carboplatin etoposide versus topotecan in patients who relapsed at least three months after the initial chemotherapy with platinum-etoposide. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate assessed by RECIST | 18 weeks | |
| Overall survival | 18 weeks | |
| Name and number of with treatment-related adverse events as assessed by CTCAE v4.0". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie BAIZE | Contact | NaBaize@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie BAIZE | Angers University Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Recruiting | Angers | 49933 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32888454 | Derived | Baize N, Monnet I, Greillier L, Geier M, Lena H, Janicot H, Vergnenegre A, Crequit J, Lamy R, Auliac JB, Letreut J, Le Caer H, Gervais R, Dansin E, Madroszyk A, Renault PA, Le Garff G, Falchero L, Berard H, Schott R, Saulnier P, Chouaid C; Groupe Francais de Pneumo-Cancerologie 01-13 investigators. Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1224-1233. doi: 10.1016/S1470-2045(20)30461-7. |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D019772 | Topotecan |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| Etoposide | Drug | Intravenous administration of 100mg/m²/day of Etoposide, Day 1 to Day 3 Every 3 weeks, maximum 6 cycles |
|
| Topotecan | Drug | Per os administration of 2.3 mg / m2 of Topotecan, Day 1 to Day 5 Every 3 weeks, maximum 6 cycles |
|
| CT scans | Device | The CT scan evaluations will be conducted during chemotherapy every 6 weeks |
|
| 18 weeks |
| The quality of life | the method of assessment : questionnaire | 18 weeks |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |