Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00003685 |
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Recruitment Status :
Completed
First Posted : May 20, 2004
Last Update Posted : April 3, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fatigue Lung Cancer Nausea and Vomiting Pain Pulmonary Complications Quality of Life | Procedure: fatigue assessment and management Procedure: nausea and vomiting therapy Procedure: pain therapy Procedure: quality-of-life assessment Radiation: radiation therapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer |
| Actual Study Start Date : | August 1, 1997 |
| Actual Primary Completion Date : | March 2001 |
| Actual Study Completion Date : | February 10, 2009 |
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| Ages Eligible for Study: | 16 Years to 120 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003685
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| Study Chair: | Andrea Bezjak, MD, MSC, FRCPC | Princess Margaret Hospital, Canada |
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00003685 |
| Other Study ID Numbers: |
SC15 CAN-NCIC-SC15 ( Other Identifier: PDQ ) CDR0000066787 ( Other Identifier: PDQ ) |
| First Posted: | May 20, 2004 Key Record Dates |
| Last Update Posted: | April 3, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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stage III non-small cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
adenosquamous cell lung cancer fatigue nausea and vomiting pain pulmonary complications quality of life |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Fatigue Nausea Vomiting Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Signs and Symptoms, Digestive |