CompletedPhase 4

STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea

United States150 participantsStarted 2002-12

Plain-language summary

Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea. This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg) of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently. In order to participate in this clinical trial, patients must be male or female 18 years of age or older. Inclusion into this investigational drug trial is based on the protocol entry criteria and a detailed evaluation from a participating trial investigator

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.

Key Inclusion criteria: * male or female patients of 18 years of age or older, scheduled or expected to receive at least two cycles of chemotherapy over at least a two- month period as primary or adjuvant therapy for any malignancy, * have experienced NCI Common Toxicity Grade 1 - 4 diarrhea during previous chemotherapy treatment or are currently experiencing Grade 1-4 diarrhea due to chemotherapy treatment Key Exclusion criteria: * females who are pregnant or lactating, * current use of anticoagulants, except for those who are receiving 1 mg/per day of Coumadin for port maintenance, * known hypersensitivity to Sandostatin, Sandostatin LAR ® Depot or other related drug or compound, * history or presence of Crohn™s disease, ulcerative colitis, sprue, or known C. difficile infection, or any other diarrheal syndrome, * WBC \< 3000 /L, Platelets \< 75,000 /L, serum creatinine \>2.0 mg/dL

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

Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy

Trial details

NCT IDNCT00050635

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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