No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Proton Collaborative Group · Research network
Who this trial is looking for
This trial is looking for patients with pancreatic cancer that cannot be surgically removed. Participants will receive proton radiation treatment along with oral chemotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with pancreatic cancer that cannot be removed.
I have borderline resectable or medically inoperable pancreatic cancer.
I am willing to use contraception if I can have children.
I have a biliary obstruction but have a drainage tube placed.
I meet the required lab test results.
You may not be able to join if
I have distant metastasis.
I have had surgery for my cancer before.
I have had another invasive cancer in the past 5 years.
I have an active or untreated infection.
I am pregnant or breastfeeding, or I cannot use contraception.
I have received radiation to my abdomen before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. It may be argued that intensification of local and regional therapy might 1.) Increase the…
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. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion 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 s…
Inclusion 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
Exclusion Criteria:
* 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 subjects 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.
Contacts
No contact information available.
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