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New treatment option for Pancreas Cancer
Official title Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)
ClinicalTrials.gov ID: NCT05191940
What this study is testing
- What it's testing
- This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.
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
- The patient has histologically or cytological confirmed diagnosis of pancreatic cancer (cases with radiological findings suspicious of pancreatic...
- The patient is not candidate for radical surgical resection because of one or more of the following reasons:
- the patient is staged as locally advanced and with unresectable disease according to the international consensus definition. Specific criteria are...
- the patient is not a candidate for radical surgery because of radiographic or biochemical (CA 19-9) progression during neoadjuvant chemotherapy...
- the patient is not candidate for radical surgery because of cN+ stage
You likely can't join if
- Non-exocrine tumors
- Major medical or psychiatric comorbidities that contraindicate radiotherapy
- Presence of distant metastasis
- Pregnancy or unwilling to do adequate conception prevention
- Lactating and unwilling to discontinue lactation
- Men of procreative potential not willing to use effective means of contraception
See the full eligibility criteria
- The patient has histologically or cytological confirmed diagnosis of pancreatic cancer (cases with radiological findings suspicious of pancreatic cancer AND elevated CA 19-9 may be enrolled even without positive...
- The patient is not candidate for radical surgical resection because of one or more of the following reasons:
- the patient is staged as locally advanced and with unresectable disease according to the international consensus definition. Specific criteria are: there is involvement of portal vein/superior mesenteric vein with...
- the patient is not a candidate for radical surgery because of radiographic or biochemical (CA 19-9) progression during neoadjuvant chemotherapy despite being initially classified as resectable or borderline resectable...
- the patient is not candidate for radical surgery because of cN+ stage
- The patient is not candidate to (further) neoadjuvant chemotherapy because of one or more of the following reasons:
- the patient is not fit for chemotherapy
- the patient has progressed under chemotherapy
- the patient has received neoadjuvant chemotherapy but is judged still not a candidate for explorative surgery.
- Negative staging for distant metastasis
- Age \> 18 years
- Karnofsky index ≥ 70
- No tumor infiltration of stomach or duodenum
- The patient is informed of the diagnosis and is able to give informed consent (Ability of patient to understand character and individual consequences of the study protocol)
- Women of fertile age must have adequate conception prevention measures and must not breast feed
- Signed Informed Consent (must be available before study inclusion)
- Non-exocrine tumors
- Major medical or psychiatric comorbidities that contraindicate radiotherapy
- Presence of distant metastasis
- Pregnancy or unwilling to do adequate conception prevention
- Lactating and unwilling to discontinue lactation
- Men of procreative potential not willing to use effective means of contraception
- Metallic prosthesis or other conditions - IF it prevents an adequate imaging for target volume definition or treatment planning at the discretion of the treating institution contraindicate radiotherapy e.g. active...
- Previous abdominal radiotherapy
- Severe hepatic or renal impairment at discretion of treating institution
- Patient refusal
The study team makes the final eligibility decision.
Where it's taking place
- Wiener Neustadt, Lower Austria, Austria
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Wiener Neustadt, Lower Austria, Austria. 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.