Symptom Control Disease Site

The Canadian Cancer Trials Group Central Operations and Statistics Centre will be closed on Friday, April 19, 2019 for Good Friday. Regular business hours will resume on Monday, April 22 at 8:30 am EDT.
ID
Sort
Study Title
 
Status
Sort  
SC26Emotion and Symptom-focused Engagement (EASE): A Randomized Controlled Trial for Individuals with Acute Leukemia
Leukemia is the 6th most common cause of cancer death in Canada, with adult acute leukemia (AL) being the most fatal form. Despite the rapid onset and life-threatening nature of AL and its treatment, little research on its psychological and physical effects and the interventions to reduce them have been done. Preliminary evidence has showed that an integrated psychosocial and early palliative intervention (e.g. EASE) reduces physical and psychological distress as compared to usual care (UC).This large, unblended phase 3 randomized controlled trial of EASE vs. UC will tests its effectiveness in reducing and preventing psychological and physical distress in adults with newly-diagnosed or relapsed AL.

Complexity Level: 2

Eligibility: Patients with newly-diagnosed or relapsed acute leukemia (AL) within 2 weeks of admission who will be receiving induction chemotherapy with curative intent. Patients must be fluent in English and must pass the cognitive screening test.

Objectives: PRIMARY OBJECTIVE: To determine the effectiveness of EASE vs. usual care (UC) to alleviate or prevent psychological distress and reduce physical symptom severity after 4 weeks of implementation. SECONDARY OBJECTIVE: (1) To determine the effectiveness of EASE vs. UC to alleviate or prevent psychological distress and reduce physical symptom severity after 8, 12, 26, and 52 weeks; and (2) to conduct post-trial, an economic analysis of EASE to determine the cost-effectiveness of EASE delivery in relation to its effect on reduction of distress in individuals with AL compared to UC.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Camilla Zimmermann, University Health Network, (416) 946-2135, (Canada) Dr. Gary Rodin, University Health Network, (416) 946-4504


Planned
SC24A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) versus Conventional Palliative Radiotherapy (CRT) for Patients with Spinal Metastases
Spinal metastases may cause severe pain and lead to fractures of vertebrae or outgrowths of tumour that compress the spinal cord resulting in paralysis. These outcomes cause considerable suffering and disability. Spinal metastases are treated with low doses of radiation and narcotic medications. Stereotactic body radiation therapy (SBRT) is a new way of providing radiation with ultra-high precision. While there is a strong biologic basis suggesting that SBRT may improve the treatment of spinal metastases, evidence from large studies (200 patients or more) is needed. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting 120 more participants.

Complexity Level: 1

Eligibility: Patients with tumours (excluding seminoma, small cell lung cancer and metastases from hematologic malignancies) who have MRI-documented spinal metastases, suitable for receiving radiation therapy, and fulfill the following criteria: (a) Pain secondary to spinal metastases requiring treatment; (b) <=3 consecutive spinal segments involved by tumour to be included in the target volume

Objectives: PRIMARY ENDPOINT: Phase II study: The ability to accrue 54 patients over an 18 month period to a study that randomizes patients with spinal metastases to Stereotactic Body Radiotherapy (SBRT) or Standard Conventional Radiotherapy (CRT) within a Canadian multicentre setting. Phase III study: To assess complete pain response in the treatment area at 3 months post-radiation. SECONDARY ENDPOINTS: (1) Complete pain response in the treatment area at 6 months post-radiation; (2) Radiation site progression-free survival (RSS PFS) at 3 and 6 months; (3) Adverse event profile; (4) Radiotherapy Quality Assurance (RTQA) compliance. TERTIARY ENDPOINT: Biobanking for future correlative Studies.

NCT Registration ID (from clinicaltrials.gov): NCT02512965
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: July 28, 2015

Chair: (Canada) Dr. Arjun Sahgal, Odette Cancer Centre, (416) 480-4834


Open to Accrual
IC1A Study of the Efficacy of Lethium in Preventing Infections in Patients With Acute Leukemia


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1979 Closing Date: June 01, 1982

Permanently Closed
IC2Protocol for the Management of Febrile Granulocytopenic Patients. Tobramycin/Ticarillin versus Moxalactam/Ticarcillin as Initial Treatment for Febrile Granulocytopenic Patients


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 31, 1981 Closing Date: October 31, 1982

Permanently Closed
IC4Comparison of Azthreonam Plus Antistaphylococcal Therapy, Azthreonam Plus Aminoglycoside, or Moxalactam Plus Aminoglycoside for the Therapy of Febrile Neutropenic Episodes in Cancer Patients Undergoing Cytotoxic Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 27, 1983 Closing Date: April 01, 1985

Permanently Closed
IC6 (46852)Empiric Antibiotic Therapy for Infection in Febrile Granulocytopenic Patients. A Prospective, Randomised Evaluation of Ceftazidime Plus Amikacin versus Ceftazidime Plus Amikacin Plus Vancomycin


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: July 01, 1986 Closing Date: December 21, 1987

Permanently Closed
IC7A Multicentric, Randomized Study to Evaluate the Safety and Efficacy of Ofloxacin versus Ofloxacin Plus Rifampin versus Norfloxacin in the Prevention of Fever and Sepsis in Patients Expected to Become Neutropenic


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 14, 1989 Closing Date: June 30, 1992

Permanently Closed
SC1A Comparison of Methylprednisolane Sodium Succinate and Metoclopramide Hydrochloride in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 30, 1982 Closing Date: March 01, 1984

Permanently Closed
SC10A Randomized Controlled Phase III Trial of Clodronate in the Treatment of Bone Pain Due to Metastatic Cancer


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 27, 1992 Closing Date: January 31, 1994

Chair: (Canada) Dr. David Warr, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2260


Permanently Closed
SC11A Phase III Double-Blind Comparison of Dolasetron Mesylate With Ondansetron and an Evaluation of the Additive Role of Dexamethasone in the Prevention of Acute (IV) and Delayed (Oral) Emesis Due to Moderately Emetogenic Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 05, 1993 Closing Date: January 27, 1995

Permanently Closed
SC12A Phase III Study of an Assessment of the Efficacy of Dexamethasone in the Prophlaxis of Radiation Induced Emesis


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 27, 1995 Closing Date: September 29, 1997

Permanently Closed
SC14A Phase III Double Blind Study of Theophylline versus Placebo for the Treatment of Dyspnea in Cancer Patients


NCT Registration ID (from clinicaltrials.gov): NCT00003684
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 24, 1998 Closing Date: November 08, 1999

Permanently Closed
SC15A Phase III Trial of Single versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patientswith Non-Small Cell Lung Cancer


NCT Registration ID (from clinicaltrials.gov): NCT00003685
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 1997 Closing Date: January 23, 2001

Chair: (Canada) Dr. Andrea Bezjak, University Health Network, (416) 946-2132


Permanently Closed
SC16A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth.


NCT Registration ID (from clinicaltrials.gov): NCT00003686
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 22, 1998 Closing Date: November 08, 1999

Chair: (Canada) Dr. David Warr, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2260


Permanently Closed
SC17A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex Sr for Chronic Cancer Pain Relief in Terminally Ill Patients


Eligibility: Patients requiring morphine for the treatment of chronic cancer pain who have been managed by a stable dose of MS contin.

Objectives: To compare the efficacy of statex SR with that of MS contin and to assess the analgesic potential of dextromethorphan with morphine SR.

NCT Registration ID (from clinicaltrials.gov): NCT00003687
Participation: Limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 11, 1998 Closing Date: July 23, 2001

Chair: (USA) Dr. Eduardo Bruera, M.D. Anderson Cancer Centre, (713) 792-6085


Permanently Closed
SC18 (989255)Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement versus Both for the Treatment of Cancer Cachexia and Anorexia
The purpose of this study is to compare the effects (good and bad) of three different treatments on your appetite and weight: 1) megestrol acetate (Megace); 2) an EPA enriched supplement; and 3) the combination of both of these agents. This study will also look for any adverse effects with these treatments, and how often they occur.

Eligibility: Histologic or cytologic proven cancer other than brain, breast, ovarian, endometrial cancer or prostate cancer. If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be known to be of brain, breast, ovarian, endometrial, or prostate cancer. Patient must be able to take oral medication reliably, and have a history of losing at least 5 pounds over the preceding two months or less.

Objectives: To compare the appetite-stimulating properties of megestrol acetate versus an eicosapentaenoic acid-enriched supplement versus both for the treatment of cancer-related (and cancer treatment related) cachexia and anorexia by following patient weight, rate of weight change, and appetite. To evaluate the effect of these treatments on nausea and vomiting in patients with advanced metastatic disease.

NCT Registration ID (from clinicaltrials.gov): NCT00031707
Participation: Limited to centres with a current CPA #.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: September 11, 2000 Closing Date: August 15, 2002

Permanently Closed
SC19A Phase III Study of Ondansetron and Dexamethasone versus Ondansetron and Placebo in the Prophylaxis Against Radiation-induced Emesis
The purpose of this study is to find out whether it is better to receive a drug called dexamethasone in addition to another called ondansetron, or to receive ondansetron alone to prevent nausea and vomiting as a result of radiation therapy. To do this, half of the patients in this study will get ondansetron plus dexamethasone and the other half will receive ondansetron plus a placebo (a substance that does not do anything).

Eligibility: Patients at risk of developing radiation-induced emesis secondary to a fractionated course of radiotherapy consisting of at least 15 fractions to a field encompassing the upper abdomen.

Objectives: To compare the effectiveness in complete protection from radiation-induced emesis and nausea using a 5-day regimen of prophylactic ondansetron and dexamethasone versus ondansetron and placebo. To compare the toxicity of the regimens and quality of life of patients in the two groups.

NCT Registration ID (from clinicaltrials.gov): NCT00016380
Participation: Not limited.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 28, 2001 Closing Date: January 31, 2004

Chair: (Canada) Dr. Rebecca Wong, University Health Network, (416) 946-2126


Permanently Closed
SC2To Evaluate the Efficacy of Methylprednisone Acetate (Depo-Medrol) in Maintaining the Anti-nauseant Effect of Methylprednisone Sodium Succinate (Solu-Medrol) in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 01, 1985 Closing Date: October 06, 1986

Permanently Closed
SC20 (SC20)A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases
The purpose of this study is to find out whether it is better to re-irradiate painful bone metastases with a single dose or with multiple smaller doses.

Complexity Level: 2

Eligibility: Patients with painful bone metastases after previous palliative radiotherapy had been given to the diseased bone.

Objectives: To assess the factors that influence response to re-irradiation and to determine the incidence of severe radiation side effects.

NCT Registration ID (from clinicaltrials.gov): NCT00080912
Participation: Not Limited.
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 07, 2004 Closing Date: May 24, 2012

Chair: (Australia) Dr. Daniel Roos, Royal Adelaide Hospital, (8) 8222-4000, (The Netherlands) Dr. Yvette van der Linden, Radiotherapeutic Institution Friesland, (58) 286-6667, (USA) Dr. William Hartsell, Advocate Good Samaritan Cancer Center, (630) 275-2300, (UK) Dr. Peter Hoskin, Univ. College of London Clinical Trials Unit, (1923) 844533, (France) Dr. Jean-Leon Lagrange, Assistance Publique Hopitaux de Paris (APHP), (14) 981-4524, (Canada) Dr. Jackson Wu, Tom Baker Cancer Centre, (403) 521-3095, (Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, (416) 480-4998


Permanently Closed
SC20U (SC20U)A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.
The purpose of this study is to compare the response to radiation treatment to biochemical changes in urine.

Complexity Level: 2

Eligibility: Patients with painful bone metasteses after previous palliative radiotherapy had been given to the diseased bone.

Objectives: To correlate the response of re-irradiation to the change of urinary markers of osteoclast activity.

Participation: Patients randomized to SC.20 in selected centres in Canada and the United Kingdom.
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 06, 2004 Closing Date: May 24, 2012

Chair: (Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, (416) 480-4998, (UK) Dr. Peter Hoskin, Univ. College of London Clinical Trials Unit, (1923) 844533


Permanently Closed
SC22A Phase I Study To Determine The Dose of Methadone As A First Line Agent In The Treatment of Chronic Neuropathic Cancer Pain.
This study is being done to find out the best starting dose of methadone for patients with chronic neuropathic cancer pain, a type of pain caused by changes to the nervous system.

Eligibility: Patients with chronic neuropathic cancer pain who need to be started on strong opioids or require an increase in their opioid dose and are currently taking opioids at a dose less than or equal to 75mg daily oral morphine equivalent.

Objectives: To determine the optimum starting dose of methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain. To assess parameters of pain control achieved with methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain including: number and timing of BTA usage, number of episodes of breakthrough pain, total daily dose of methadone, average pain score. To determine the safety and adverse event profile of methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain. To assess the frequency and severity of sleep disturbance associated with the use of methadone. To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone versus morphine.

NCT Registration ID (from clinicaltrials.gov): NCT00930332
Participation: Limited to Canadian centres with a physician licensed to prescribe methadone.
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 17, 2009 Closing Date: May 16, 2011

Permanently Closed
SC23A Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases.
Some patients who receive radiation therapy to treat painful bone metastases from their main cancer experience a temporary increase in pain at the treated site before they experience pain relief. This is called pain flare. This study evaluates if taking a drug called dexamethasone once a day for 5 days (starting 1 hour before radiotherapy) can prevent pain flare.

Complexity Level: 2

Eligibility: Cancer patients requiring treatment with radiotherapy in a single fraction of 8 Gy for bone metastases in one or two painful areas.

Objectives: - To compare the effectiveness of prophylactic dexamethasone versus placebo in protecting against radiation-induced pain flare associated with a single 8 Gy course of treatment by examining the difference in incidence of pain flare in the first 10 days after therapy. - To compare in patients treated with dexamethasone versus placebo: the incidences of pain flare occurring on Days 0-5 and Days 6-10; the nature, severity and frequencies of adverse events; and quality of life. - To validate the EORTC QLQ-BM22 module with the EORTC QLQ-C15-PAL. - To investigate if pain flare following palliative radiotherapy is correlated with a surge of inflammatory cytokines and baseline levels of the bone turnover markers pyridinoline and N-telopeptide. - To investigate if dexamethasone prophylaxis is mediated through a decrease in inflammatory cytokines and if prophylaxis failure is due to rapid metabolism of drug, intrinsic glucocorticoid recepter defects or variations in SNPs.

NCT Registration ID (from clinicaltrials.gov): NCT01248585
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 22, 2010 Closing Date: December 12, 2014

Chair: (Canada) Dr. Alysa Fairchild, Cross Cancer Institute, (780) 432-8516, (Canada) Mr. Carlo De Angelis, Odette Cancer Centre, (416) 480-6100 Ext. 1085, (Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, (416) 480-4998


Permanently Closed
SC4A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BrL 43694a in Comparison With High Dose Metoclopromide, Dexamethasone and Diphenhydramine in Patients Receiving Highly Emetogenic Cisplatin Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 08, 1988 Closing Date: July 31, 1989

Permanently Closed
SC5A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BRL 43694a in Comparison With Dexamethasone and Prochlorperazine in Patients Receiving Moderately Emetogenic Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 08, 1988 Closing Date: March 03, 1989

Permanently Closed
SC6An Assessment of the Antiemetic Efficacy, Tolerance, and Safety of GR38032f versus Dexamethasone Plus Metoclopramide in Patients With Breast Cancer Receiving "CMF" Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 20, 1989 Closing Date: November 02, 1990

Permanently Closed
SC7A Randomized Double-Blind Efficacy, Safety and Pharmacokinetic Study of Six Doses of the Antiemetic BMY-25801 and Methylprednisone Among Out-Patients Receiving Moderately Emetogenic Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 14, 1989 Closing Date: February 16, 1990

Permanently Closed
SC8A Double Blind Comparator Study for the Prophylactic Use of Granisetron Both Alone and in Combination With Dexamethasone Over a 7 Day Period in Controlling Nausea and Vomiting Associated With High Dose Cisplatin Therapy in Patients With Malignant Disease


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 25, 1991 Closing Date: June 20, 1994

Permanently Closed
SC9An Assessment of the Effect of Schedule and Maintenance on the Antiemetic Efficacy and Safety of Ondansetron Combined With Dexamethasone as Acute and Maintenance Therapy in Patients Receiving Moderately Emetogenic Chemotherapy


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 01, 1991 Closing Date: August 02, 1991

Chair: (Canada) Dr. Leonard Kaizer, Credit Valley Hospital, (905) 813-1100 Ext. 5135


Permanently Closed