CompletedPhase 2

Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

France120 participantsStarted 2011-06

Plain-language summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery.

Who can participate

Age range

18 Years – 120 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 adenocarcinoma of the pancreas * No metastatic or locally advanced (nonresectable) disease * Must have undergone curative surgical resection * Must have macroscopically complete (R0 or R1) surgical outcome * Adjuvant treatment with gemcitabine hydrochloride (for 6 months) is necessary, and able to start treatment within 8 weeks of surgical resection * No ampullomas or endocrine carcinomas PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatases ≤ 5 times upper limit of normal * Total bilirubin ≤ 50 µmol/L * Creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Able to start adjuvant chemotherapy within 8 weeks of surgery * No evolving infectious syndrome (fever \> 38°C or abscess) * No contraindication for gemcitabine hydrochloride * No prior malignant tumor except for cutaneous basocellular carcinoma or in situ cervical epithelioma (prior history of malignant tumor diagnosed and treated more than 10 years ago allowed, except for breast cancer and melanoma) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No chemotherapy or radiotherapy within the past 10 years * No prior ablation surgery leaving macroscopic tumor residues (R2)

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

capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine

Timeframe: 2 months

Trial details

NCT IDNCT01416662

SponsorFederation Francophone de Cancerologie Digestive

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

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