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Radiation Therapy Plus Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

NCT01134861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2015-03-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

cisplatin

100 mg/m2 i.v. over 30-60 minutes, days 1 \& 29

DRUG

Etoposide

Oral etoposide given 50 mg b.i.d. X 10 only on RT treatment days 1-5, 8-12, 29-33, and 36-40. 75 mg/day if body surface area \< 1.7 m2

DRUG

Vinblastine

5 mg/m2 i.v. bolus weekly first 5 weeks of RT

RADIATION

Radiation therapy

63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fX) beginning day 50 of protocol treatment

DRUG

Cisplatin

50 mg/m2 i.v. over 30-60 minutes on days 1, 8, 29, and 36

RADIATION

Radiation therapy

63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fx) beginning day 1 of protocol treatment

RADIATION

Radiation therapy

69.6 Gy/6 wks/58 X 1.2 Gy twice daily fractions (at least 6 hours apart) beginning day 1 of protocol therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Walter J. Curran, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-07-31
Primary Completion
1998-10-31
Completion
2012-03-31

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Entities

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134861 on ClinicalTrials.gov