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SC28

The SEEMLESS Study: A randomized trial of a SmartphonE App-based MindfuLnEss intervention for cancer SurvivorS


Complexity Level: 3

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, (403) 355-3207


Planned
SC26

Emotion and Symptom-focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention 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 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 reduce psychological distress and physical symptom severity in adults with newly diagnosed acute leukemia after 8 weeks of implementation. SECONDARY OBJECTIVE: (1) To determine the effectiveness of EASE vs. UC to reduce psychological distress and physical symptom severity after 4 and 12 weeks, 6 months, and 1 year; (2) to determine the effects of EASE vs UC on other domains of health-related quality of life; and (3) 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.

NCT Registration ID (from clinicaltrials.gov): NCT04224974
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: December 23, 2019

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


Open to Accrual
IC8

COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure


Complexity Level: 2

Eligibility: Patients must be: -undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma, requiring them to present to the hospital or cancer clinic at least twice/month for assessments and/or treatments, anticipated for at least 3 months. - have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old; Hypertension (on medications); Type 1 or 2 Diabetes (on medication); A relevant chronic condition as per the investigator based on the medical record including heart, lung, liver and/or serious kidney disease; receiving systemic therapy; Body Mass Index > 40; Living in a nursing home or long term care facility. - Age 18 or greater and an ECOG PS of 0-2

Objectives: Primary objective: to investigate the effectiveness of IMM 101 at preventing "influenza-like illnesses" (ILI), as defined by the WHO, OR a confirmed viral/bacterial respiratory infection (via microbiology or radiography), AND that results in a change or delay in a priori planned cancer treatment or requirement for an unscheduled medical assessment (i.e. emergency room visit, family physician assessment, etc.), hospitalization, or death compared to control subjects. Numerous Secondary and Tertiary/Exploratory Objectives planned.

NCT Registration ID (from clinicaltrials.gov): NCT04442048
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: June 25, 2020 Closing Date: May 14, 2021

Chair: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 72791


Closed to Accrual
ICC1 (NCICOVID)

NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study


Complexity Level: 3

Eligibility: Patients must have a prior or current cancer diagnosis, that fits into one of the following categories: - Patient is receiving active treatment (current or within the last 6 weeks) for metastatic cancer - Patient is receiving adjuvant treatment + had IV chemotherapy, immuno or targeted therapy, endocrine therapy, or RT in the last 6 weeks - Patient received ASCT, CAR-T or modified cell therapy at any time - Patient is receiving treatment or prophylaxis or host disease, or received bone marrow transplant within the past 2 years. Patients must have had a positive COVID-19 test within the last 14 days using any specimen source. Patients with brain mets or HIV are eligible. Co-enrollment on other clinical trials is allowed.

Objectives: 1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 2. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 3. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics. 4. Correlative study objectives by collection, storage, and research of blood specimens and radiological images.

NCT Registration ID (from clinicaltrials.gov): NCT04387656
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: June 18, 2020 Closing Date: February 01, 2022

Chair: (Canada) Dr. Nathalie Daaboul, Hopital Charles LeMoyne, (450) 466-5000


Closed to Accrual
SC27

Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of the COVID-19 Pandemic on Cancer Patients During Treatment and Survivors


Complexity Level: 3

Eligibility: >=18 years of age: any cancer diagnosis in the last 10 years, any stage; must be able to read/ write english or french

Objectives: Primary objectives 1. Describe the pattern of psychosocial and physical symptom severity, and QOL over time and differences by sub-groups (e.g., age, gender, cancer stage) 2. Assess participants' perceptions of their experience and satisfaction of cancer care over time 3. Identify the coping strategies, and health and safety actions used by patients and survivors during cancer diagnosis, treatment, and recovery in the context of COVID-19 Secondary objectives 4. Examine factors associated with psychosocial and physical symptom severity, poor QOL and other clinical outcomes (e.g., COVID-19 status, hospitalization, and mortality). 4a. Explore effect modification by selected subgroups (e.g., age, sex, gender, cancer stage)

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: June 30, 2020 Closing Date: August 16, 2022

Chair: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, (403) 355-3207


Closed to Accrual
IC1

A 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
IC2

Protocol 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
IC4

Comparison 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


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: 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


NCT Registration ID (from clinicaltrials.gov): no NCT
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
IC7

A 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


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: July 14, 1989 Closing Date: June 30, 1992

Permanently Closed
SC1

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


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: October 30, 1982 Closing Date: March 01, 1984

Permanently Closed
SC10

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


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 27, 1992 Closing Date: January 31, 1994

Permanently Closed
SC11

A 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


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: May 05, 1993 Closing Date: January 27, 1995

Permanently Closed
SC12

A Phase III Study of an Assessment of the Efficacy of Dexamethasone in the Prophlaxis of Radiation Induced Emesis


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 27, 1995 Closing Date: September 29, 1997

Permanently Closed
SC14

A 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
SC15

A 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

Permanently Closed
SC16

A 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

Permanently Closed
SC17

A 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

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


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
SC19

A Phase III Study of Ondansetron and Dexamethasone versus Ondansetron and Placebo in the Prophylaxis Against Radiation-induced Emesis


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

Permanently Closed
SC2

To 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


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 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


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

Permanently Closed
SC20U (SC20U)

A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.


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.

NCT Registration ID (from clinicaltrials.gov): no NCT
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

Permanently Closed
SC22

A Phase I Study To Determine The Dose of Methadone As A First Line Agent In The Treatment of Chronic Neuropathic Cancer Pain.


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
SC23

A Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases.


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

Permanently Closed
SC4

A 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


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: April 08, 1988 Closing Date: July 31, 1989

Permanently Closed
SC5

A 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


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: April 08, 1988 Closing Date: March 03, 1989

Permanently Closed
SC6

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


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: July 20, 1989 Closing Date: November 02, 1990

Permanently Closed
SC7

A 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


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: February 14, 1989 Closing Date: February 16, 1990

Permanently Closed
SC8

A 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


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 25, 1991 Closing Date: June 20, 1994

Permanently Closed
SC9

An 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


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 01, 1991 Closing Date: August 02, 1991

Permanently Closed