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

NCT ID: NCT01745445

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

concurrent chemo-radiotherapy arm

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

QING SONG PANG, M.D

Role: STUDY_DIRECTOR

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Locations

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

QING SONG PANG, M.D

Role: CONTACT

pangqingsong@yahoo.com.cn

+86-22-23340123-1314

Facility Contacts

QING SONG PANG, M.D

Role: primary

pangqingsong@yahoo.com.cn

+86-22-23340123-1314

References

Zhao J, Zhang W, Er P, Chen X, Guan Y, Qian D, Wang J, Yuan Z, Zhao L, Wang P, Pang Q. Concurrent or Sequential Chemoradiotherapy after 3-4 Cycles Induction Chemotherapy for LS-SCLC with Bulky Tumor. J Cancer. 2020 Jun 16;11(17):4957-4964. doi: 10.7150/jca.41136. eCollection 2020.

Reference Type: DERIVED

PMID: 32742443 (View on PubMed)

Other Identifiers

CIH-PQS-201205001

Identifier Type: -

Identifier Source: org_study_id