Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen

NCT00016380 | Completed Phase 3 DMC

• 3 other identifiers: SC19CAN-NCIC-SC19CDR0000068627
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 14

Brief Summary

RATIONALE: Antiemetic drugs may help to reduce or prevent vomiting in patients treated with radiation therapy. It is not yet known if ondansetron is more effective with or without dexamethasone in preventing vomiting caused by radiation therapy. PURPOSE: This randomized phase III trial is comparing how well ondansetron works with or without dexamethasone in preventing vomiting in patients with cancer who are receiving radiation therapy to the upper abdomen.

Conditions

Cancer

Keywords

nausea and vomiting; stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; recurrent colon cancer; recurrent cervical cancer; stage IB cervical cancer; stage IIB cervical cancer; stage IVB cervical cancer; stage IA cervical cancer; stage IIA cervical cancer; stage IVA cervical cancer; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; localized gastrointestinal carcinoid tumor; regional gastrointestinal carcinoid tumor; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; localized resectable adult primary liver cancer; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; small intestine adenocarcinoma; small intestine lymphoma; small intestine leiomyosarcoma; localized gallbladder cancer; unresectable gallbladder cancer; recurrent gallbladder cancer; localized extrahepatic bile duct cancer; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; testicular seminoma; carcinoma of the appendix; quality of life; stage IV pancreatic cancer

Interventions

dexamethasone DRUG

ondansetron DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Cancer patients who are scheduled to receive radiotherapy within the next 3 weeks * Total dose at least 2,000 cGy delivered in at least 15 fractions * 1 fraction per day, 5 days per week * Treatment field to include an area of at least 80 cm2 in the anterior/posterior direction encompassing the upper abdomen * At risk of developing radiation-induced emesis * No emesis (retching and/or vomiting) or nausea with severity greater than 2 within the past week PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No jaundice * No moderate to severe hepatic dysfunction Renal: * Not specified Gastrointestinal: * No active peptic ulcer * No lactose intolerance Other: * No concurrent condition or illness that contraindicates corticosteroids, serotonin antagonists, or prochlorperazine (e.g., diabetes mellitus) * No prior unusual or allergic reaction to a serotonin antagonist (ondansetron, dolasetron, or granisetron), corticosteroid, or prochlorperazine * No condition that would preclude accessibility to treatment or follow-up * Able and willing to complete diary and quality of life questionnaires in either English or French * Able to swallow PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 1 week since prior cytotoxic therapy * No concurrent cytotoxic therapy Endocrine therapy: * No concurrent corticosteroids other than topical or inhaled preparations Radiotherapy: * See Disease Characteristics * At least 1 week since prior radiotherapy * No concurrent cranial radiotherapy Surgery: * Not specified Other: * At least 2 days since prior medication with antiemetic intent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (14)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Northwestern Ontario Regional Cancer Care

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H4L 2M1, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (4)

• National Cancer Institute of Canada Clinical Trials Group (SC19); Wong RK, Paul N, Ding K, Whitehead M, Brundage M, Fyles A, Wilke D, Nabid A, Fortin A, Wilson D, McKenzie M, Ackerman I, Souhami L, Chabot P, Pater J. 5-hydroxytryptamine-3 receptor antagonist with or without short-course dexamethasone in the prophylaxis of radiation induced emesis: a placebo-controlled randomized trial of the National Cancer Institute of Canada Clinical Trials Group (SC19). J Clin Oncol. 2006 Jul 20;24(21):3458-64. doi: 10.1200/JCO.2005.04.4685.

  PMID: 16849762 RESULT

• Paul N, Wong R, Brundage Michael, et al.: Symptom assessment in SC19: ondansetron plus dexamethasone as prophylaxis against radiation-induced emesis - a National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study. [Abstract] Support Care Cancer 13 (6): A-04-033, 419, 2005.

  RESULT

• Paul N, Wong R, Whitehead M, et al.: Daily diary reporting of symptoms in SC19: a National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study of prophylaxis against radiation-induced emesis. [Abstract] Support Care Cancer 13 (6): A-04-034, 419, 2005.

  RESULT

• Wong R, Paul N, Ding K, et al.: Optimizing prophylaxis of radiation induced emesis (RIE): a phase III double blind randomized study comparing ondansetron plus dexamethasone (OndDex) vs ondansetron alone (OndPlac). [Abstract] Support Care Cancer 13 (6): A-04-043, 423, 2005.

  RESULT

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting; Colonic Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Uterine Cervical Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Hepatocellular; Gallbladder Neoplasms; Bile Duct Neoplasms; Seminoma; Appendiceal Neoplasms

Interventions

Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Adenocarcinoma; Liver Neoplasms; Liver Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Bile Duct Diseases; Germinoma; Neoplasms, Germ Cell and Embryonal; Cecal Neoplasms; Cecal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Rebecca Wong, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: February 28, 2001
• Primary Completion: April 30, 2004
• Study Completion: February 10, 2009
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)