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FatiguePhase 3NCT00003685

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

A Phase 3 study testing fatigue assessment and management, nausea and vomiting therapy and pain therapy in people with Fatigue and Lung Cancer, run by NCIC Clinical Trials Group at 21 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 120 years
Conditions the study is for
Fatigue, Lung Cancer, Nausea and Vomiting
What is being tested?
fatigue assessment and management, nausea and vomiting therapy and pain therapy
Type of treatment
Surgery or procedure
How many people
230 participants
Where
21 sitesCanada
Study dates
1 Aug 1997to 10 Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Canada21 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Doctor Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario, K1H 8L6

  • Ottawa Regional Cancer Centre - Civic Campus

    Ottawa, Ontario, K1Y 4K7

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Hotel Dieu Hospital - St. Catharines

    St. Catharines, Ontario, L2R 5K3

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 1J8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
fatigue assessment and management, nausea and vomiting therapy, pain therapy, quality-of-life assessment, radiation therapy
Keywords
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
Medical subject headings
Fatigue, Lung Neoplasms, Nausea, Vomiting, Pain, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fatigue assessment and managementProcedure or surgery

  • nausea and vomiting therapyProcedure or surgery

  • pain therapyProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2004 (estimated)
  2. Study start1 Aug 1997
  3. Primary completionMar 2001
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003685
Sponsor's protocol ID
SC15
Other IDs
CAN-NCIC-SC15, CDR0000066787
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
3 Apr 2020
Results posted
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12377323

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fatigue assessment and management, nausea and vomiting therapy and pain therapy in people with Fatigue and Lung Cancer, run by NCIC Clinical Trials Group at 21 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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