Carbon Ion RT for Locally Advanced Pancreatic Cancer

  • End date
    Sep 1, 2025
  • participants needed
  • sponsor
    Nitin Ohri
Updated on 23 March 2022
chemotherapy drug
neutrophil count
cancer chemotherapy


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.

Condition Pancreatic Cancer
Treatment Chemotherapy drug, carbon ion RT
Clinical Study IdentifierNCT04592861
SponsorNitin Ohri
Last Modified on23 March 2022


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
Active malignancy, other than pancreatic cancer, for which systemic therapy is
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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