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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Locoregionally advanced, inoperable, non-small cell lung cancer
with no evidence of distant metastases, i.e.: Stage II/IIIA medically inoperable disease
Stage IIIA/IIIB unresectable disease No pleural effusion Appearance after an invasive
thoracic procedure allowed No more than 5% weight loss within 3 months prior to diagnosis
Confirmed N2 disease should first be evaluated for protocol RTOG-9309

PATIENT CHARACTERISTICS: Age: At least 18 Performance status: Karnofsky 70%-100%
Hematopoietic: AGC at least 2,000 Platelets at least 100,000 Hemoglobin at least 8.0 g/dL
Hepatic: (unless abnormality caused by benign disease) Bilirubin no more than 1.5 times
normal AST no more than 1.5 times normal Renal: Creatinine no more than 1.5 mg/dL
Cardiovascular: No myocardial infarction within the past 6 months No angina No congestive
heart failure No uncontrolled arrhythmia Other: No synchronous or prior invasive
malignancy within 3 years except nonmelanomatous skin cancer No pregnant women Effective
contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck
radiotherapy Surgery: No prior complete or nearly complete tumor resection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

from date of randomization to date of death or last follow-up for patients still alive

Safety Issue:

No

Principal Investigator

Walter J. Curran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

RTOG-9410

NCT ID:

NCT01134861

Start Date:

July 1994

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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