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AzTrials

Anal CancerPhase 3NCT00075868

Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer

A Phase 3 study testing octreotide acetate in people with Anal Cancer and Colorectal Cancer, run by Radiation Therapy Oncology Group at 112 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
octreotide acetate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
233 participants
Where
112 sitesUnited States
Study dates
Dec 2003to Aug 2006
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 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary anal or rectal cancer
  • No metastasis beyond the pelvic regional nodes
  • Must be scheduled to receive chemoradiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Liver function tests < 3 times upper limit of normal
  • No prior hepatic disease

Renal

  • Not specified

Gastrointestinal

  • No prior chronic or acute regional enteritis
  • No malabsorption syndrome
  • No prior inflammatory bowel disease that may exacerbate the radiotherapy toxicity
  • No grade 2 or greater uncontrollable diarrhea at baseline
  • No prior cholecystitis or gallstones, unless a cholecystectomy has been performed
  • No prior incontinence of stool

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No uncontrolled diabetes (e.g., fasting glucose > 250 mg/dL)
  • No prior allergy or hypersensitivity to study drug or other related drug or compound
  • No other medical condition or mental impairment that would preclude study treatment and compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Prior chemotherapy allowed

Endocrine therapy

  • At least 6 months since prior administration of any of the following:
  • Glucocorticoid therapy
  • Insulin sensitizers (e.g., metformin, pioglitazone, or rosiglitazone)
  • Exogenous growth hormone therapy

Radiotherapy

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior intensity-modulated radiotherapy
  • No concurrent radiotherapy for abdominal cancer
  • No concurrent hyperfractionated, split-course, or intensity-modulated radiotherapy
  • No brachytherapy prior to or after completion of all external beam radiotherapy

Surgery

  • No prior abdominal-perineal resection or other surgical procedure leaving the patient without a functioning rectum
  • No colostomy

Other

  • More than 30 days since other prior investigational drugs
  • No prior octreotide for cancer therapy-related diarrhea
  • No concurrent prophylactic antidiarrheal medication

Trial locations and contacts

112 sites in 1 country.

112 sites in 1 country

United States112 sites

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • St. John's Cancer Center at St. John's Medical Center

    Anderson, Indiana, 46016

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Long Island College Hospital

    Brooklyn, New York, 11201

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Camden, New Jersey, 08103

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • John B. Amos Community Cancer Center

    Columbus, Georgia, 31904

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Saint Agnes Medical Center

    Fresno, California, 93720-3397

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis

    Indianapolis, Indiana, 46202

  • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

    Inglewood, California, 90301

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Columbia St. Mary's Cancer Center

    Milwaukee, Wisconsin, 53211

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Leavey Cancer Center at Northridge Hospital Medical Center

    Northridge, California, 91328

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Mercy Cancer Institute at Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Washoe Cancer Services at Washoe Medical Center - Reno

    Reno, Nevada, 89502

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

    Salem, Ohio, 44460

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Community Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Torrance Memorial Medical Center

    Torrance, California, 90509

  • Fox Chase Cancer Center at St. Francis Medical Center

    Trenton, New Jersey, 08629

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • LaFortune Cancer Center at St. John Medical Center

    Tulsa, Oklahoma, 74104

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • South Jersey Healthcare Regional Cancer Center

    Vineland, New Jersey, 08360

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • West Allis Memorial Hospital

    West Milwaukee, Wisconsin, 53227

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled Phase III Study To Determine The Efficacy Of Sandostatin LAR® Depot (Octreotide Acetate) In Preventing Or Reducing The Severity Of Chemoradiation-Induced Diarrhea In Patients With Anal Or Rectal Cancer

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea.

PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the ability of octreotide to prevent the incidence of moderate, severe, or life-threatening chemoradiotherapy-induced diarrhea (grades 2-4) in patients with anal or rectal cancer.

Secondary

  • Compare the quality of life of patients treated with this drug vs placebo.
  • Compare the number of hospitalizations and use of antidiarrheal agents (e.g., Imodium®) related to diarrhea (or its complications) in patients treated with these drugs.
  • Compare treatment delays and/or dose reductions (chemotherapy and radiotherapy) in patients treated with these drugs.

OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to radiotherapy dose (< 50 Gy vs ≥ 50 Gy), chemotherapy dose (bolus vs continuous), and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive octreotide* intramuscularly (IM) 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.
  • Arm II: Patients receive placebo* IM 4-7 days before the start of chemoradiotherapy and on day 22 (± 3 days) during chemoradiotherapy.

NOTE: *Patients receive a total of 2 injections of octreotide or placebo

In both arms, treatment continues in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, at the completion of chemoradiotherapy, and at 3, 6, 9, and 15 months from the start of chemoradiotherapy.

Patients are followed at 3, 6, 9, and 15 months from the start of chemoradiotherapy.

PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 2 years.

Being tested
octreotide acetate, Placebo
Keywords
radiation enteritis, drug/agent toxicity by tissue/organ, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IIIA anal cancer, stage IIIB anal cancer, recurrent anal cancer, stage I anal cancer, stage II anal cancer, recurrent rectal cancer
Medical subject headings
Anus Neoplasms, Colorectal Neoplasms, Drug-Related Side Effects and Adverse Reactions, Rectal Neoplasms

What participants receive

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

  • octreotide acetateDrug

  • PlaceboOther

Study groups in NCT00075868
Study groupRoleWhat they receive
Sandostatin LAR® DepotExperimentalSandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Receives: Drug: octreotide acetate
PlaceboPlacebo comparatorPlacebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention of the incidence of moderate, severe, or life-threatening diarrhea

Secondary outcomes (4)

  1. Quality of life

  2. Economic measures

  3. Validity of the Functional Alterations due to Changes in Elimination-Changes in Bowel Function, the Quality of Life-Radiation Therapy Instrument, and the Expand Prostate Index Composite-Bowel questionnaires

  4. Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea

Timeline

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

  1. First posted13 Jan 2004 (estimated)
  2. Study startDec 2003
  3. Primary completionAug 2006

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075868
Sponsor's protocol ID
RTOG-0315
Other IDs
CDR0000349441
Status last verified
Nov 2015
First submitted
9 Jan 2004
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zachariah B, Gwede CK, James J, Ajani J, Chin LJ, Donath D, Rosenthal SA, Kane BL, Rotman M, Berk L, Kachnic LA. Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: randomized RTOG trial 0315. J Natl Cancer Inst. 2010 Apr 21;102(8):547-56. doi: 10.1093/jnci/djq063. Epub 2010 Mar 25.

    PubMed 20339140

  • Zachariah B, James J, Gwede CK, et al.: RTOG 0315: a randomized, double-blind, placebo-controlled phase III study to determine the efficacy of octreotide acetate in preventing or reducing the severity of chemoradiation-induced diarrhea in patients with anal or rectal cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-4032, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing octreotide acetate in people with Anal Cancer and Colorectal Cancer, run by Radiation Therapy Oncology Group at 112 sites in United States.

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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States. 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. Some participants in this study may receive a placebo. 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.

What does the primary outcome measure?

Prevention of the incidence of moderate, severe, or life-threatening diarrhea. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00075868, which also lists 2 linked publications.

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 17 Nov 2015.

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