CompletedPhase 3

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

130 participantsStarted 2002-04

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 oc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 2 years

Trial details

NCT IDNCT00033605

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-07

View on ClinicalTrials.gov More Cervical Cancer trials