A Phase 3 interventional study of Carboplatin and Etoposide in Small Cell Lung Cancer, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-25.
Sponsored by University Hospital, Angers · Phase 3, Interventional, and Treatment
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
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 164 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
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
Drug: Carboplatin · Drug: Etoposide · Device: CT scans
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
Drug: Topotecan · Device: CT scans
Intravenous administration of Carboplatin AUC 5 at Day 1, Every 3 weeks, maximum 6 cycles
Intravenous administration of 100mg/m²/day of Etoposide, Day 1 to Day 3 Every 3 weeks, maximum 6 cycles
Per os administration of 2.3 mg / m2 of Topotecan, Day 1 to Day 5 Every 3 weeks, maximum 6 cycles
The CT scan evaluations will be conducted during chemotherapy every 6 weeks
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.
Time frame: 18 weeks
Objective response rate assessed by RECIST
Time frame: 18 weeks
Overall survival
Time frame: 18 weeks
Name and number of with treatment-related adverse events as assessed by CTCAE v4.0".
Time frame: 18 weeks
The quality of life
the method of assessment : questionnaire
Time frame: 18 weeks
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers