A Phase 3 interventional study of octreotide acetate and Placebo in Anal Cancer, Colorectal Cancer and Drug/Agent Toxicity by Tissue/Organ, sponsored by Radiation Therapy Oncology Group. Completed at 112 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Supportive care
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Among 162 studies in Anus Neoplasms with a site in United States — 28 open to participants now, 42 under way, 3 of them phase 3. Anus Neoplasms · United States.
Among the 162 studies in Anus Neoplasms with a site in United States, this one is the 19th largest by enrollment of the 128 interventional ones that give a count, is one of 6 that started in 2003, is one of 9 in phase 3, and was the 22nd registered.
298 studies on the registry are indexed under Anus Neoplasms; 75 are open to participants now.
Browse Anus Neoplasms studies →28 of the 162 studies in Anus Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
InduPro, Inc. · Sites in United States
Ages 18+
Jennifer Dorth · Sites in United States
Ages 18+
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 50+ · Women only
Alliance for Clinical Trials in Oncology · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Anus Neoplasms studies recruiting now, 46 (81%) set no upper age limit and 7 (12%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
162 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 54 · Phase 2 52 · Phase 3 10
First in 1994; this study’s year is marked. 6 started in 2003.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 233 is above the median of 65 across 212 interventional studies indexed under Anus Neoplasms.
Median enrollment 49 across the 128 interventional studies, 99 across the 32 observational. Of the 112 that completed or were terminated, 41 (37%) have results posted.
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32 of 162 have an industry lead sponsor. The 10 most frequent:
Radiation Therapy Oncology Group is the lead sponsor of 155 studies on the registry; none are open to participants now.
Radiation Therapy Oncology Group has 3 studies filed under Anus Neoplasms — fewer than ten, so there is no comparison to draw.
13 of the studies in Anus Neoplasms with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04444921Phase 3National Cancer Institute (NCI)EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients | 2027-03-31 |
| NCT07407647Ohio State University Comprehensive Cancer CenterVaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer | 2026-12-31 |
| NCT05838391Columbia UniversityAdaptive Radiation in Anal Cancer | 2026-12-31 |
| NCT05217940Icahn School of Medicine at Mount SinaiScreening Women With Prior HPV for Anal Neoplasia | 2027-01 |
| NCT05941507LigaChem Biosciences, Inc.A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors | 2027-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 162 studies in Anus Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
OBJECTIVES:
Primary
Secondary
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.
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.
DISEASE CHARACTERISTICS:
confirmed primary anal or rectal cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 6 months since prior administration of any of the following:
Radiotherapy
Surgery
Other
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sandostatin LAR® Depot Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Drug: octreotide acetate
Placebo Pre-RT (between day -7 and day -4 of RT) and Day 22 (± 3 days)
Other: Placebo
Prevention of the incidence of moderate, severe, or life-threatening diarrhea
Quality of life
Economic measures
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
Prevention of the incidence of severe or life-threatening (i.e., grade 3-5) diarrhea
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The record gives a start of Dec 2003 and a primary completion of Aug 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Octreotide
Radiation Therapy Oncology Group →