BridgeMD
New treatment option for Pancreatic Cancer
Official title Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
ClinicalTrials.gov ID: NCT02598349
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pancreatic cancer.
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Biopsy proven unresectable adenocarcinoma of the pancreas.
- Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
- A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
- Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
- Required pretreatment laboratory parameters:
You likely can't join if
- Evidence of distant metastasis.
- Prior surgical resection.
- Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has...
- Active or untreated infection,
- Pregnant or breastfeeding women or people of child producing potential not willing to use medically acceptable contraception while on treatment and...
- Previous Radiation to the abdomen.
See the full eligibility criteria
- Biopsy proven unresectable adenocarcinoma of the pancreas.
- Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
- A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
- Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
- Required pretreatment laboratory parameters:
- Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
- Platelet count ≥ 100,000/mm3
- Bilirubin \< 2 mg/dl
- ALT/SGPT \< 3x upper limit of normal
- Creatinine \< 3 mg/dl
- Evidence of distant metastasis.
- Prior surgical resection.
- Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
- Active or untreated infection,
- Pregnant or breastfeeding women or people of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
- Previous Radiation to the abdomen.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Warrenville, Illinois, United States
- Flint, Michigan, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Warrenville, Illinois, United States; Flint, Michigan, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.