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NCT00003685 · CITED IN SOURCE DOCUMENTS

Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-04-03

RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung cancer. It is not yet known which regimen of radiation therapy is most effective in relieving symptoms in patients with non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer Squamous cell lung cancer Large cell lung cancer Adenocarcinoma lung cancer Mixture of above Locally advanced disease for which the patient declined aggressive treatment or that is unsuitable for aggressive curative treatment due to at least one of the following: Performance status of ECOG 2 or 3 Otherwise unexplained weight loss greater than 10% in the last 6 months Bulky disease that cannot be irradiated safely to high doses Inability to tolerate chemotherapy Cytologically positive pleural effusion OR Clinically or radiologically proven metastatic disease for which palliative chemotherapy is not planned in the first 38 days after radiotherapy No more than one brain metastasis allowed One of the following symptoms identified as the index symptom: Loss of appetite Nausea Vomiting Cough Coughing up blood Chest pain Shortness of breath Difficulty swallowing Fatigue Must have symptoms related to intrathoracic lung cancer that are amenable to radiation palliation PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-3 Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fluent in English or French No loss of sight or other inability to complete questionnaires or diary Not pregnant No concurrent terminal illness No other active malignancy that is causing symptoms or is expected to progress in the next 3 months PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 30 days since prior chemotherapy and failed No planned chemotherapy within 38 days after study treatment Endocrine therapy: Not specified Radiotherapy: No planned laser therapy within 38 days after study treatment Surgery: At least 30 days since prior surgery and failed Other: No planned photodynamic therapy or sclerotherapy within 38 days after study treatment
healthy Volunteers
false
maximum Age
120 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    fatigue assessment and management
    type
    PROCEDURE
  2. name
    nausea and vomiting therapy
    type
    PROCEDURE
  3. name
    pain therapy
    type
    PROCEDURE
  4. name
    quality-of-life assessment
    type
    PROCEDURE
  5. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
230
type
ACTUAL
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Radiation therapy may relieve symptoms in patients with non-small cell lung cancer. It is not yet known which regimen of radiation therapy is most effective in relieving symptoms in patients with non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy to relieve symptoms in patients who have non-small cell lung cancer.
detailed Description
OBJECTIVES: I. Compare the efficacy of two schedules of radiotherapy in the palliation of symptoms in patients with non-small cell lung cancer. II. Compare the toxicity of these two regimens in these patients. III. Compare the quality of life and survival of patients treated with these two regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, weight loss in the previous 6 months (no greater than 10% vs greater than 10%), and performance status (ECOG 0 or 1 vs 2 or 3). Patients are randomized to undergo radiotherapy as 5 fractions over 5 days or 1 fraction on 1 day. Quality of life is assessed before treatment, weekly for 5 weeks, and monthly thereafter. Patients are followed weekly for 5 weeks, then every 2 months for 1 year. PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.
Source references
references
  1. citation
    Bezjak A, Dixon P, Brundage M, Tu D, Palmer MJ, Blood P, Grafton C, Lochrin C, Leong C, Mulroy L, Smith C, Wright J, Pater JL; Clinical Trials Group of the National Cancer Institute of Canada. Randomized phase III trial of single versus fractionated thoracic radiation in the palliation of patients with lung cancer (NCIC CTG SC.15). Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):719-28. doi: 10.1016/s0360-3016(02)02989-9.
    pmid
    12377323
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        for symptom relief compared with hypofractionated or standard regimens, as seen in the NCIC Clinical Trials Group trial (<a href="/clinicaltrials/NCT00003685">NCT00003685</a>).[<a href="#cit/section_9.59">59</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021&amp;version=HealthProfessional&amp;language=English" onclick="ja
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        compared with hypofractionated or standard regimens, as shown in the National Cancer Institute of Canada Clinical Trials Group trial (<a href="/clinicaltrials/NCT00003685">NCT00003685</a>).[<a href="#cit/section_10.28">28</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021&amp;version=HealthProfessional&amp;language=Englis
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        hypofractionated or standard regimens, as shown in the National Cancer Institute of Canada Clinical Trials Group trial (<a href="/clinicaltrials/NCT00003685">NCT00003685</a>).[<a href="#cit/section_10.28">28</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021&amp;version=HealthProfessional&amp;language=English" onclick="j
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        gle-fraction radiation may be insufficient for symptom relief compared with hypofractionated or standard regimens, as evidenced in the <a href="/clinicaltrials/NCT00003685">NCT00003685</a> trial.[<a href="#cit/section_11.21">21</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021&amp;version=HealthProfessional&amp;language=E
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        exact text
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      6. context exact
        radiation may be insufficient for symptom relief compared with hypofractionated or standard regimens, as evidenced in the <a href="/clinicaltrials/NCT00003685">NCT00003685</a> trial.[<a href="#cit/section_11.21">21</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810021&amp;version=HealthProfessional&amp;language=English" oncli
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      source title
      Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice