Carbon Ion RT for Locally Advanced Pancreatic Cancer

STATUS

Recruiting
End date

Sep 1, 2025
participants needed

137
sponsor

Nitin Ohri

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Updated on 23 March 2022

See if I qualify

chemotherapy drug

neutrophil count

cancer chemotherapy

adenocarcinoma

celiac

Summary

This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.

Details

Condition	Pancreatic Cancer
Treatment	Chemotherapy drug, carbon ion RT
Clinical Study Identifier	NCT04592861
Sponsor	Nitin Ohri
Last Modified on	23 March 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
	Sum of maximum diameters of tumor and involved lymph nodes ≤6 cm T1-4N0-1M0
	Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following
	major venous thrombosis of the portal vein or SMV extending for several centimeters
	(precluding vein resection and reconstruction) encasement (>180°) of the SMA or proximal
	hepatic artery abutment of the celiac trunk
	No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the
	ECOG Performance Status 0-1 within 30 days prior to registration
	chest, abdomen, and pelvis within 30 days prior to registration
	Age ≥ 18
	CBC/differential obtained within 14 days prior to step 1 registration, with adequate
	bone marrow function defined as follows
	Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
	Platelets ≥ 100,000 cells/mm3
	Additional laboratory studies within 14 days prior to registration demonstrating
	Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve
	Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)
	Bilirubin < 1.5 x ULN
	Hgb ≥ 9.0 g/dl is acceptable)
	Patients must provide study specific informed consent prior to study entry
	ALT and AST ≤ 2.5 x ULN
	aPTT, PT ≤ 1.5 x ULN
	Women of childbearing potential and male participants must practice adequate
	contraception during protocol treatment and for at least 6 months following treatment
	For females of child-bearing potential, negative serum pregnancy test within 30 days
	prior to registration
Exclusion Criteria
	More than one primary lesion
	Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
	FOLFIRINOX
	Gemcitabine/nab-paclitaxel
	Gemcitabine
	Active malignancy, other than pancreatic cancer, for which systemic therapy is
	S-1
	indicated. -History of adequately treated local basal cell or squamous cell carcinoma
	of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic
	prostate cancer without known metastatic disease and with no requirement for therapy
	asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in
	complete remission, or any other cancer that has been in complete remission for ≥ 5
	years is permitted
	Prior treatment for pancreatic cancer with surgical resection, external radiotherapy
	or interstitial isotope implantation
	Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not
	included in the list below. Systemic therapy must be discontinued at least 14 days
	before study enrollment
	Prior radiation therapy to the abdomen that would result in overlap of radiation
	therapy fields

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Carbon Ion RT for Locally Advanced Pancreatic Cancer