- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003685
Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
A Phase III Trial of Single Versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patients With Non-Small Cell Lung Cancer
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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Surrey, British Columbia, Canada, V3V 1Z2
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
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Victoria, British Columbia, Canada, V8R 1J8
- British Columbia Cancer Agency - Vancouver Island Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
- Doctor Leon Richard Oncology Centre
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Saint John, New Brunswick, Canada, E2L 4L2
- Saint John Regional Hospital
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Kingston Regional Cancer Centre
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Ottawa, Ontario, Canada, K1Y 4K7
- Ottawa Regional Cancer Centre - Civic Campus
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Regional Cancer Center - General Division
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Peterborough, Ontario, Canada, K9H 7B6
- Peterborough Oncology Clinic
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St. Catharines, Ontario, Canada, L2R 5K3
- Hotel Dieu Hospital - St. Catharines
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Sudbury, Ontario, Canada, P3E 5J1
- Northeastern Ontario Regional Cancer Centre, Sudbury
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Thunder Bay, Ontario, Canada, P7A 7T1
- Northwestern Ontario Regional Cancer Centre, Thunder Bay
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Windsor, Ontario, Canada, N8W 2X3
- Cancer Care Ontario - Windsor Regional Cancer Centre
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Andrea Bezjak, MD, MSC, FRCPC, Princess Margaret Hospital, Canada
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SC15
- CAN-NCIC-SC15 (Anden identifikator: PDQ)
- CDR0000066787 (Anden identifikator: PDQ)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Livskvalitet
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NorthShore University HealthSystemUkendt
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Marlene FischerAfsluttetPostoperativ Quality of Recovery på postanæstesiafdelingenTyskland
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Ondokuz Mayıs UniversityRekrutteringKejsersnit | Intratekal morfin | Quality of Recovery 40Kalkun
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Anqing Municipal HospitalAfsluttetDexmedetomidin | Lidokain | Quality of Recovery (QoR-40), præoperativ og postoperativKina
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Riyadh Elm UniversityAfsluttetOral Health Related Quality of Life OHRQoLSaudi Arabien
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University of British ColumbiaUkendtDelirium | Kognitiv tilbagegang | Post-operative Quality of RecoveryCanada
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University of MalayaUkendtTranspalatal bue (TPA) | Oral Health Related Quality of Life (OHRQoL) | Oral Health Impact Profile Short Version 14 (OHIP 14) | Ortodontiske smerter | Tredimensionel (3D) ortodontisk enhedMalaysia
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University Hospital, GrenobleUkendtHealth Care Quality Management (ingen betingelse).Frankrig
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Prisma Health-UpstateNational Institute on Drug Abuse (NIDA); Clemson UniversityRekrutteringStandard for pleje | Standard of Care + CBT4CBT | Standard of Care + CBT4CBT + RCForenede Stater
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Sorbonne UniversityAalborg UniversityRekrutteringPoint of Care UltralydFrankrig
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