Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002577

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed.

Condition	Intervention	Phase
Lung Cancer	Radiation: radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY POST INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE, NON-SMALL CELL LUNG CANCER

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	36
Study Start Date:	July 1995

Detailed Description:

OBJECTIVES: I. Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy (3D-CRT) in patients with locally advanced, inoperable, non-small cell lung cancer. II. Determine the maximum tolerated dose of 3D-CRT in these patients. III. Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung.

OUTLINE: This is a dose escalation study. Patients are stratified by the percentage of total lung volume (TLV) receiving greater than 20 Gy of radiation (less than 25% vs 25% to less than 37% vs at least 37%). As of 7/1/1999, the third stratum closed to accrual. Patients receive 3-dimensional conformal radiotherapy (3D-CRT) 5 days a week for either 6-7 weeks, 7-8 weeks, or 9-10 weeks (depending on the cohort). Within each TLV stratum, cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 15% of patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-36 patients per cohort will be accrued for this study within 1 year. As of 7/1/1999, the third stratum closed to accrual.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer of the following histologic types: Squamous cell carcinoma Adenocarcinoma Undifferentiated large cell carcinoma Not otherwise specified (i.e., diagnosis by cytology alone) Unresectable stage I, II, or III disease Measurable lesion Primary and nodal lesions encompassable within radiotherapy fields No positive supraclavicular lymph nodes (stage N3) No massive atelectasis No complete remission if treated with chemotherapy Prior cisplatin, vinblastine, etoposide, paclitaxel, carboplatin, or vinorelbine allowed All chemotherapy delivered within 4 months of entry No pleural effusion with positive cytology Other pleural effusions eligible with following requirements: Present prior to mediastinoscopy or exploratory thoracotomy Transudate cytologically negative on 2 separate thoracenteses OR Present after mediastinoscopy or exploratory thoracotomy Either transudate or exudate with negative cytology on thoracentesis OR Present only on CT and not on chest x-ray Too small to tap under CT or ultrasound guidance Ineligible for treatment on RTOG phase III studies

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic response modifier therapy Chemotherapy: See Disease Characteristics At least 6 months since prior bleomycin, mitomycin, doxorubicin, or cyclophosphamide No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic irradiation Surgery: Ineligible for definitive surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002577

Show 242 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Mary V. Graham, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Werner-Wasik M, Swann RS, Bradley J, Graham M, Emami B, Purdy J, Sause W. Increasing Tumor Volume is Predictive of Poor Overall and Progression-Free Survival: Secondary Analysis of the Radiation Therapy Oncology Group 93-11 Phase I-II Radiation Dose-Escalation Study in Patients with Inoperable Non-Small-Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2007 Sep 13; [Epub ahead of print]

Bradley J, Deasy J, Naqa IE, et al.: Predictors of lung toxicity from the RTOG 9311 radiation dose escalation trial: GTV position is important. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-67, S40, 2005.

Bradley J, Graham MV, Winter K, Purdy JA, Komaki R, Roa WH, Ryu JK, Bosch W, Emami B. Toxicity and outcome results of RTOG 9311: a phase I-II dose-escalation study using three-dimensional conformal radiotherapy in patients with inoperable non-small-cell lung carcinoma. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):318-28.

Bradley JD, Graham MV, Winter KW, et al.: Acute and late toxicity results of RTOG 9311: a dose escalation study using 3D conformal radiation therapy in patients with inoperable non-small cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S137-8, 2003.

Graham MV, Winter K, Purdy JA, et al.: Preliminary results of a Radiation Therapy Oncology Group trial (RTOG 9311): a dose escalation study using 3d conformal radiation therapy in patients with inoperable nonsmall cell lung cancer. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-34, 19-20, 2001.

Bradley J. A review of radiation dose escalation trials for non-small cell lung cancer within the Radiation Therapy Oncology Group. Semin Oncol. 2005 Apr;32(2 Suppl 3):S111-3. Review.

Study ID Numbers:	CDR0000063662, RTOG-9311
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002577 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer

large cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009