An interventional study of prophylactic cranial irradiation (PCI) and lobectomy + mediastinal lymph node dissection or systematic lymph node sampling in Small-cell Lung Cancer, sponsored by Peng Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Peng Zhang · Not applicable, Interventional, and Treatment
At present, for participants with cT1-2N0 small cell lung cancer (SCLC), the International guidelines recommend surgical radical resection (lobectomy + systematic lymph node sampling or cleaning); If the postoperatively pathological examination is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If participants are difficult to tolerate the side effects of cisplatin, the investigators can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme. Participants with pT1-2N0 SCLC are not recommended to receive postoperative chest-assisted radiotherapy. For participants with pT1-N0 SCLC after specific surgical resection, prophylactic cranial irradiation (PCI) is currently recommended. But this recommendation is currently lacking the support of research evidence.
The main purpose of this study is to study the prognostic effects of PCI on participants with pT1-2N0 stage small cell lung cancer (SCLC) who have received radical surgery and postoperative adjuvant chemotherapy.
The main endpoint of this study is to observe the total survival rate (5-year OS%) in 5 years.
The secondary outcome measures include 5 years of disease-free survival (5-year DFS%), disease-free survival (DFS), overall survival (OS), surgical complications, resection rates, quality of life (QoL), and exploration of biomarkers (tumor tissue).
This is a two-arm, open, multicentral clinical study designed to compare the 5-year OS% of participants receiving or not receiving PCI for pT1-2N0 stage small cell lung cancer (SCLC) with radical surgery plus postoperative adjuvant chemotherapy. Previous literature reports that the 5-year OS% of participants with pT1-2N0 period SCLC who have received surgical resection is about 50%. Assuming that PCI can increase 5 years OS% by 10%, then enrolling 320 participants in the group can guarantee 70% degree of certainty with observing a unilateral significant difference α\< 0.1. Taking about 10% of the follow-up loss rate into account, the investigators expect to enroll 360 participants.
Dividing the 360 participants divided into two groups randomly, each group is composed of 180 people. All participants received lobectomy plus mediastinal lymph node dissection or systematic lymph node sampling. Participants in the control group are enrolled in the follow-up, and the participants in research group will receive PCI by 25gy/10fx.
Exclusion Criteria:
Procedure: prophylactic cranial irradiation (PCI) · Procedure: lobectomy + mediastinal lymph node dissection or systematic lymph node sampling · Drug: postoperative adjuvant chemotherapy
Procedure: lobectomy + mediastinal lymph node dissection or systematic lymph node sampling · Drug: postoperative adjuvant chemotherapy
Patients in the control group are enrolled in the follow-up, and the patients in research group will receive prophylactic cranial irradiation (PCI) by 25 gy/10 fx.
lobectomy + mediastinal lymph node dissection or systematic lymph node sampling
If the postoperatively pathological examination of the patient is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If patients are difficult to tolerate the side effects of cisplatin, we can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme.
5-year overall survival rate(5-y OS%)
Five-year survival rate measures survival at 5 years after surgery.
Time frame: From the completion of the intervention to 5 years.
5-year disease-free survival rate (5-y DFS%)
The rate that the patients whose disease doesn't recur take up in the total patients from the start of randomization to 5 years.
Time frame: From the completion of the intervention to 5 years.
disease-free survival period
From the beginning of randomization to the time-point when the disease recurs or the patient dies due to disease progression.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
overall survival (OS)
Patients die directly from the progression of SCLC or from an unrelated cause (for example, a car accident). When the precise cause of death is not specified, this is called the overall survival rate.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
surgery complications
The complications related to the operations that happen in the perioperative period.
Time frame: Within 2 weeks includes surgery and perioperative period.
removal rate
The patients who are able to receive the radical resection.
Time frame: Through study completion, an average of 1 year.
tumor biological makers
To search the possible bio-makers for SCLC.
Time frame: Within 2 weeks includes surgery and perioperative period.
Plan to share: Undecided
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Peng Zhang