Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01745445
First received: December 6, 2012
Last updated: April 22, 2014
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Other: concurrent chemo-radiotherapy arm
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    OS was defined as the length of time from the date of randomization to the date of death of various reasons.

  • acute and late toxic effects [ Time Frame: 3 months and 3 years ] [ Designated as safety issue: No ]
    acute toxic effect was defined as toxic effects less than 90 days from initiation of treatment late toxic effect was defined as toxic effects more than 90 days from initiation of treatment


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiotherapy alone arm
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; All patients will be radiated by external beam radiation, using 3-D conformal radiation technique.
Other: concurrent chemo-radiotherapy arm
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.

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.

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745445

Contacts
Contact: QING SONG PANG, M.D +86-22-23340123-1314 pangqingsong@yahoo.com.cn

Locations
China, Tianjin
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: QING SONG PANG, M.D    +86-22-23340123-1314    pangqingsong@yahoo.com.cn   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Director: QING SONG PANG, M.D Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01745445     History of Changes
Other Study ID Numbers: CIH-PQS-201205001
Study First Received: December 6, 2012
Last Updated: April 22, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
limited-stage small cell lung cancer
concurrent chemo-radiotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014