Back to results

Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer

Primary Purpose

Limited Disease Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy

About this trial

This is an interventional treatment trial for Limited Disease Small Cell Lung Cancer focused on measuring concurrent chemoradiation in patients with limited disease small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed SCLC
Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g. Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral hilum/supraclavicular lymph node invasion).
Measurable or assessable lesion
Age over 18 years old
Performance status (ECOG scale): 0~2
Adequate organ functions: ANC ≥ 1500/ul, PLT ≥ 100 x 103/u, Total Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 1.5 mg/dl
Inclusion of tumor within the limited radiation field without significant loss of pulmonary function (confirmed by radiation oncologist)
Sexually active fertile men and women using a contraceptive method
Patients should sign a written informed consest before study entry

Exclusion Criteria:

T4 disease with malignant pleural effusion; N3 disease with contralateral hilum/supraclavicular lymph node invasion
Lesion with mixed small cell nonsmall cell feature (pathologically)
prior chemotherapy or radiation therapy.
Pericardial or pleural effusion on chest X-ray image regardless of cytological finding
T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; Concerns about possible perforation by tumor necrosis
Severe comorbidities such as cardiac disease with symptom, myocardiac infarction within 6 months, chronic obstructive pulmonary disease with FEV1 less than 1.0ℓ, or uncontrolled bronchospasm of unaffected lung
With atelectasis that makes GTV unidentifiable
Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago without recurrence)
Uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug addiction and central nervous system disease

Sites / Locations

National Cancer Canter, KoreaRecruiting
National Cancer Canter, KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1(with twice-daily TRT)

Arm 2 (with once-daily TRT)

Arm Description

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT01710956

First Posted

October 16, 2012

Last Updated

October 17, 2012

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT01710956

Brief Title

Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer

Official Title

Randomized Phase II Study of Once Daily Accelerated Fractionation With Concomitant Boost to the Gross Tumor Volume Compared With Twice Daily Hyperfractionation in Concurrent Chemoradiation in Patients With Limited Disease Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Non-small cell lung cancer

6. Conditions and Keywords

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

Limited Disease Small Cell Lung Cancer

Keywords

concurrent chemoradiation in patients with limited disease small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1(with twice-daily TRT)

Arm Type

Experimental

Arm Title

Arm 2 (with once-daily TRT)

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy

Intervention Description

Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)

Primary Outcome Measure Information:

Title

progression free survival

Time Frame

5years after chemoradiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically (if cannot be proven histologically, at least twice positive findings on fine needle aspiration or sputum cytology) confirmed SCLC Limited stage (Clinical stage I-IIIb, lesion limited to one side of thorax, e.g. Excluding T4 disease with malignant pleural effusion or N3 disease with contralateral hilum/supraclavicular lymph node invasion). Measurable or assessable lesion Age over 18 years old Performance status (ECOG scale): 0~2 Adequate organ functions: ANC ≥ 1500/ul, PLT ≥ 100 x 103/u, Total Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 1.5 mg/dl Inclusion of tumor within the limited radiation field without significant loss of pulmonary function (confirmed by radiation oncologist) Sexually active fertile men and women using a contraceptive method Patients should sign a written informed consest before study entry Exclusion Criteria: T4 disease with malignant pleural effusion; N3 disease with contralateral hilum/supraclavicular lymph node invasion Lesion with mixed small cell nonsmall cell feature (pathologically) prior chemotherapy or radiation therapy. Pericardial or pleural effusion on chest X-ray image regardless of cytological finding T4 disease with tumor invasion to great vessels, heart, trachea, or esophagus; Concerns about possible perforation by tumor necrosis Severe comorbidities such as cardiac disease with symptom, myocardiac infarction within 6 months, chronic obstructive pulmonary disease with FEV1 less than 1.0ℓ, or uncontrolled bronchospasm of unaffected lung With atelectasis that makes GTV unidentifiable Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 3 years ago without recurrence) Uncontrolled psychiatric disorder, serious head injury, chronic alcoholism, drug addiction and central nervous system disease

Central Contact Person:

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

Kwan Ho Cho, M.D.

Phone

+82 31 920 1720

kwancho@ncc.re.kr

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

Sung Ho Moon, M.D.

Phone

+82 31 920 1726

shmoon@ncc.re.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwan Ho Cho, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Canter, Korea

City

Ilsan-ro 323, Ilsandoung-gu, Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kwan Ho Cho, M.D.

Phone

+82 31 920 1720

ncckrog@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Sung Ho Moon, M.D.

Phone

+82 31 920 1726

ncckrog@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Sung Ho Moon, M.D.

First Name & Middle Initial & Last Name & Degree

Jin Soo Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Heung Tae Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Ji Youn Han, M.D.

First Name & Middle Initial & Last Name & Degree

Tak Yun, M.D

First Name & Middle Initial & Last Name & Degree

Young Joo Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Geon Kook Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Hyae Young Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Byung Ho Nam, Statistician

Facility Name

National Cancer Canter, Korea

City

Ilsan-ro 323, Ilsandoung-gu, Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kwan Ho Cho, M.D.

Phone

+82 31 920 1720

kwancho@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Sung Ho Moon, M.D.

Phone

+82 31 920 1726

shmoon@ncc.re.kr

First Name & Middle Initial & Last Name & Degree

Sung Ho Moon, M.D.

First Name & Middle Initial & Last Name & Degree

Jin Soo Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Heung Tae Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Ji Youn Han, M.D.

First Name & Middle Initial & Last Name & Degree

Tak Yun, M.D

First Name & Middle Initial & Last Name & Degree

Young Joo Lee, M.D.

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs