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Cervical CancerPhase 3NCT00033605

Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis

A Phase 3 study testing octreotide acetate and radiation in people with Cervical Cancer and Colorectal Cancer, run by Alliance for Clinical Trials in Oncology.

Completed

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

Official record
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Trial summary

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Cancer, Colorectal Cancer, Diarrhea
What is being tested?
octreotide acetate and radiation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
No sites listed yet
Study dates
Apr 2002to Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer in the pelvis
  • Plan to receive continuous definitive or adjuvant external-beam radiotherapy to the pelvis or pelvis and para-aortic lymph nodes (total planned dose of 4,500-5,350 cGy)
  • Entire pelvis must be encompassed by planned radiotherapy field (superior border not inferior to the most inferior aspect of sacroiliac joints)
  • Portions of rectum may have special blocking depending on disease site
  • Planned treatment for once-daily radiotherapy 4-5 times a week (planned daily dose 170-210 cGy)
  • No planned split-course radiotherapy
  • No planned interstitial brachytherapy prior to completion of external-beam radiotherapy
  • Planned intracavitary radiotherapy allowed
  • No planned cytotoxic chemotherapy agents concurrently with radiotherapy except fluorouracil with or without leucovorin calcium or cisplatin
  • Entered on study before the third radiotherapy fraction
  • No current or prior metastases beyond pelvic or para-aortic lymph nodes
  • No grade 3 or greater diarrhea, rectal bleeding, or abdominal cramping prior to radiotherapy
  • No incontinence of stool

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Renal:

  • No chronic renal failure
  • Creatinine less than 2 times upper limit of normal (for patients with history of renal disease)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known allergy to octreotide
  • No history of inflammatory bowel disease
  • No other concurrent medical condition that would preclude study participation
  • No history of cholecystitis unless prior cholecystectomy

PRIOR CONCURRENT THERAPY:

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the pelvis

Surgery:

  • See Disease Characteristics
  • No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure resulting in non-functioning rectum

About this study

Official title: Phase III Double-Blind Study Of Depot Octreotide Versus Placebo In The Prevention Of Acute Diarrhea In Patients Receiving Pelvic Radiation Therapy

RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing radiation therapy to the pelvis. It is not yet known whether octreotide is effective for diarrhea.

PURPOSE: Randomized phase III trial to determine the effectiveness of octreotide in preventing diarrhea in patients who are undergoing radiation therapy to the pelvis.

Read the detailed description

OBJECTIVES:

  • Determine the effectiveness of octreotide in reducing acute treatment-related diarrhea in patients receiving external-beam radiotherapy to the pelvis.
  • Determine the effectiveness of this drug in reducing chronic treatment-related bowel dysfunction in these patients.
  • Determine the toxicity of this drug in these patients.
  • Assess the importance that these patients attach to various measures of bowel function.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior anterior resection of the rectum (yes vs no), total planned cumulative dose of radiotherapy, including boost fields (4,500-5,350 cGy vs 5,351-6,000 cGy vs more than 6,000 cGy), use of concurrent fluorouracil (none vs bolus vs continuous infusion), use of concurrent leucovorin calcium (yes vs no), use of concurrent cisplatin (yes vs no), superior border of initial field (at or inferior to the L4-5 interspace vs superior to the L4-5 interspace), planned intracavitary brachytherapy (yes vs no), and primary site of disease (rectal cancer vs prostate cancer vs gynecological cancer vs other). Beginning no later than the fourth day of radiotherapy, patients are randomized to one of two treatment arms.

  • Arm I: Patients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29.
  • Arm II: Patients receive placebo SC on day 1 and IM on days 2 and 29. In both arms, treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea.

Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy.

Patients are followed weekly for 4 weeks and then at 1 and 2 years.

Being tested
octreotide acetate, placebo, radiation
Medical subject headings
Uterine Cervical Neoplasms, Colorectal Neoplasms, Diarrhea, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Sarcoma

What participants receive

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

  • octreotide acetateDrug

  • placeboOther

  • radiationRadiation

Study groups in NCT00033605
Study groupRoleWhat they receive
octreotide + radiationExperimentalPatients receive short-acting octreotide subcutaneously (SC) on day 1 and long-acting octreotide intramuscularly (IM) on days 2 and 29. Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea. Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy. Patients are followed weekly for 4 weeks and then at 1 and 2 years.
Receives: Drug: octreotide acetate; Radiation: radiation
placebo + radiationActive comparatorPatients receive placebo SC on day 1 and IM on days 2 and 29. Treatment continues in the absence of unacceptable toxicity or the development of severe diarrhea. Patients complete a bowel function questionnaire at baseline, weekly during radiotherapy, and then weekly for 4 weeks and at 1 and 2 years after completion of radiotherapy. Patients are followed weekly for 4 weeks and then at 1 and 2 years.
Receives: Other: placebo; Radiation: radiation

What is being measured

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

  1. Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Reduction of patient-reported bowel dysfunction as assessed by the bowel function questionnaire weekly during radiotherapy, weekly for 4 weeks after radiotherapy, and 12 and 24 months after completion of radiotherapy

    Measured: Up to 2 years

  2. Toxicity as assessed by NCI CTC version 2.0 weekly during pelvic radiotherapy

    Measured: Up to 2 years

  3. Importance that patients attach to various measures of bowel dysfunction as assessed by questionnaire at week 4 of radiotherapy and at 12 and 24 months after completion of radiotherapy

    Measured: Up to 2 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Primary completionJul 2006
  4. Study completionJul 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
Who is masked
Participant, Investigator
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033605
Sponsor's protocol ID
NCCTG-N00CA
Other IDs
CDR0000069304, NCI-P02-0221
Status last verified
Jul 2016
First submitted
9 Apr 2002
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Martenson JA, Halyard MY, Sloan JA, Proulx GM, Miller RC, Deming RL, Dick SJ, Johnson HA, Tai TH, Zhu AW, Keit J, Stien KJ, Atherton PJ. Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA. J Clin Oncol. 2008 Nov 10;26(32):5248-53. doi: 10.1200/JCO.2008.17.1546. Epub 2008 Sep 2.

    PubMed 18768432

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing octreotide acetate and radiation in people with Cervical Cancer and Colorectal Cancer, run by Alliance for Clinical Trials in Oncology.

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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Reduction of diarrhea as measured by NCI CTC version 2.0 weekly during pelvic radiotherapy (time frame: Up to 2 years). 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 NCT00033605, which also lists 1 linked publication.

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 13 Jul 2016.

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