Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy
17 Years
75 Years
Both
Small Cell Lung Cancer
Trial Information
Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy
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.
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;
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease free survival
Outcome Description:
DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of SCLC or any other type of cancer or death.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
QING SONG PANG, M.D
Investigator Role:
Study Director
Investigator Affiliation:
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Authority:
China: Food and Drug Administration
Study ID:
CIH-PQS-201205001
NCT ID:
NCT01745445
Start Date:
January 2012
Completion Date:
February 2014
Related Keywords:
- Small Cell Lung Cancer
- limited-stage small cell lung cancer
- concurrent chemo-radiotherapy
- Lung Neoplasms
- Small Cell Lung Carcinoma
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