Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT01134861
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2010-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy Plus Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Study Overview
Official Title:
A Three-Arm Phase III Study of Concomitant Versus Sequential Chemotherapy and Thoracic Radiotherapy for Patients With Locally Advanced Inoperable Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of various schedules of radiation therapy and combination chemotherapy using vinblastine and cisplatin or cisplatin and etoposide in treating patients with stage II or stage III non-small cell lung cancer that cannot be removed surgically.
PURPOSE: Randomized phase III trial to compare the effectiveness of various schedules of radiation therapy and combination chemotherapy using vinblastine and cisplatin or cisplatin and etoposide in treating patients with stage II or stage III non-small cell lung cancer that cannot be removed surgically.
Detailed Description:
OBJECTIVES: I. Compare the survival rate of patients with locally advanced, unresectable non-small cell lung cancer randomized to concomitant vinblastine/cisplatin (VBL/CDDP) and thoracic radiotherapy versus sequential VBL/CDDP and once-daily thoracic radiotherapy. II. Compare the survival rate of such patients randomized to 2 courses of concomitant etoposide/cisplatin and hyperfractionated thoracic radiotherapy versus sequential VBL/CDDP and once-daily thoracic radiotherapy. III. Assess the frequency of treatment-related esophageal and hematologic toxicity/morbidity in patients on concomitant versus sequential chemoradiation treatment arms.
OUTLINE: Randomized study. The following acronyms are used: CDDP Cisplatin, NSC-119875 VBL Vinblastine, NSC-49842 VP-16 Etoposide, NSC-141540 Arm I: 2-Drug Combination Chemotherapy Followed by Radiotherapy. CDDP/VBL; followed by thoracic irradiation using photons of at least 6 MV (electrons may be used to boost the supraclavicular lymph nodes). Arm II: Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VBL. Arm III: Hyperfractionated Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VP-16.
PROJECTED ACCRUAL: A total of 597 patients will be entered over 3.1-4.2 years. If fewer than 6 patients/month are accrued, the feasibility of the study will be re-evaluated.
OUTLINE: Randomized study. The following acronyms are used: CDDP Cisplatin, NSC-119875 VBL Vinblastine, NSC-49842 VP-16 Etoposide, NSC-141540 Arm I: 2-Drug Combination Chemotherapy Followed by Radiotherapy. CDDP/VBL; followed by thoracic irradiation using photons of at least 6 MV (electrons may be used to boost the supraclavicular lymph nodes). Arm II: Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VBL. Arm III: Hyperfractionated Radiotherapy plus 2-Drug Combination Chemotherapy. Thoracic irradiation using equipment as in Arm I; plus CDDP/VP-16.
PROJECTED ACCRUAL: A total of 597 patients will be entered over 3.1-4.2 years. If fewer than 6 patients/month are accrued, the feasibility of the study will be re-evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA021661 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000063640 | OTHER | Radiation Therapy Oncology Group | View |