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

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

concurrent chemo-radiotherapy arm

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring limited-stage small cell lung cancer, concurrent chemo-radiotherapy

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Department of Radiation Oncology, Tianjin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy alone arm

Arm Description

Outcomes

Primary Outcome Measures

disease free survival

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

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

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

Full Information

NCT ID

NCT01745445

First Posted

December 6, 2012

Last Updated

May 15, 2016

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01745445

Brief Title

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

Acronym

SCLC

Official Title

Phase ⅡClinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

limited-stage small cell lung cancer, concurrent chemo-radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy alone arm

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

concurrent chemo-radiotherapy arm

Intervention 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.

Primary Outcome Measure Information:

Title

disease free survival

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

overall survival

Description

OS was defined as the length of time from the date of randomization to the date of death of various reasons.

Time Frame

3 years

Title

acute and late toxic effects

Description

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

Time Frame

3 months and 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

QING SONG PANG, M.D

Phone

+86-22-23340123-1314

pangqingsong@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

QING SONG PANG, M.D

Organizational Affiliation

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

QING SONG PANG, M.D

Phone

+86-22-23340123-1314

pangqingsong@yahoo.com.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32742443

Citation

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.

Results Reference

derived

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

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