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Trial Title:
Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC)
NCT ID:
NCT01745445
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
limited-stage small cell lung cancer
concurrent chemo-radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
concurrent chemo-radiotherapy arm
Description:
VP-16 50 mg/m2 on day 1-5 and Carboplatin AUC = 5 on day 1 will be given by intravenous
infusion for 3-4 cycles. Then a total dose of 60 Gy will be given in 30 fractions of 2
Gy, 5 fractions per week; Starting the first cycle of concurrent chemotherapy at the
first day of radiotherapy. The chemotherapeutic scheme is intravenous infusion of
Cisplatin 25mg/m2 on day 1-3 and oral administration of Etoposide 100mg on day1-5 and 3
weeks as a cycle for 2 consecutive cycles.
Arm group label:
radiotherapy alone arm
Summary:
This trial aims to evaluate the efficacy and safety between radiotherapy alone and
concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.
Detailed description:
Small cell lung cancer (SCLC) represents 15-30% of all lung malignancies in China.
Limited-stage small cell lung cancer (LS-SCLC) represents approximately 40% of cases. The
current standard of care in limited-stage disease is systemic chemotherapy plus
concurrent thoracic radiotherapy. Early concurrent chemo-radiotherapy is recommended for
patients with limited-stage SCLC based on randomized trials. But, the administration of
thoracic radiotherapy requires the assessment of several factors, including the volume of
the radiation port, dose of radiation, and fractionation of radiotherapy. Parts of the
LS-SCLC are local advanced stage (stage Ⅲa and Ⅲb), which can not tolerate concurrent
chemo-radiotherapy because of large size in tumor and extensive metastasis of lymph
nodes. At present, it is usually use 3-4 cycles of introduction chemotherapy to decrease
the tumor size followed by definitive radiotherapy. But it is unclear whether this scheme
is tolerant well or it could improve the overall survival in patients with LS-SCLC. As a
result, we designed a prospective phase II randomized controlled trial in order to
compare the tolerance and therapeutic effects between radiotherapy alone and concurrent
chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Age 18- 75 years; ECOG performance status 0 or 1; Pathological or cytological
confirmation of SCLC; Local stage small cell lung cancer with stage Ⅲa and Ⅲb; Receive
3-4 cycles of chemotherapy with etoposide plus cisplatin; Measurable disease using RECIST
criteria with at least one lesion;
Adequate hematological, renal, hepatic and pulmonary functions defined as:
granulocytes ≥ 2.0×109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 8g/L, total bilirubin ≤
1.5 x upper normal limit, aspartate aminotransferase, alanine aminotransferase≤2.5 ×
upper normal limit,, creatinine ≤ 1.5mg/L, FEV1 ≥ 1.5 L Ability to understand and
willingness to sign a written informed consent form;
Exclusion Criteria:
History of operation of lung cancer; PD after 3-4 cycles chemotherapy; Patients with
sever infection; Patients with uncontrollable diabetes; Patients in pregnancy or
lactation; Patients who are currently receiving or have received other clinical trail for
radioprotection within the prior six months are excluded; Patient with history of
malignancy other than skin cancer or Carcinoma in-situ within 2 years; History of
cardiovascular diseases that might include one of the following: myocardial infraction,
angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass
surgery in the last 6 months; Concomitant treatment with other anticancer drugs;
Gender:
All
Minimum age:
17 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
QING SONG PANG, M.D
Phone:
+86-22-23340123-1314
Email:
pangqingsong@yahoo.com.cn
Start date:
January 2012
Completion date:
December 2016
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01745445
