Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)
Phase II Trial of Hypo-fractionated Highly Conformal Radiotherapy for Locally Advanced Pancreatic Carcinomas
EBG MedAustron GmbH
30 participants
May 16, 2022
INTERVENTIONAL
Conditions
Summary
This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.
Eligibility
Inclusion Criteria16
- 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 cytology)
- 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 bilateral narrowing/occlusion, exceeding the inferior border of the duodenum; or tumor contact/invasion of 180 or more degree of the superior mesenteric artery or of the truncus coeliacus; or tumor contact/invasion of the proper hepatic artery/ celiac artery; or tumor contact or invasion of the aorta.
- 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 according to the international consensus definition.
- 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)
Exclusion Criteria10
- 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 infections in the area
- Previous abdominal radiotherapy
- Severe hepatic or renal impairment at discretion of treating institution
- Patient refusal
Interventions
According to the radiation plan (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).
Evaluation before treatment-start, after treatment and follow-up period.
For treatment planning as well as for follow-up radiological tumor assessment.
For treatment planning as well as for follow-up radiological tumor assessment.
For treatment planning as well as for follow-up radiological tumor assessment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05191940