Carbon Ion RT for Locally Advanced Pancreatic Cancer

NCT ID: NCT04592861

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-08-24

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbon ion radiotherapy

Carbon ion radiotherapy will be administered 5 days each week (Monday-Friday). The prescription dose will be 60 GyE in 20 fractions, to be delivered over four weeks.

Group Type: EXPERIMENTAL

carbon ion RT

Intervention Type: RADIATION

daily carbon ion radiotherapy

Chemotherapy drug

Intervention Type: DRUG

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.

Routine standard of care

Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.

Group Type: ACTIVE_COMPARATOR

Chemotherapy drug

Intervention Type: DRUG

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.

Interventions

carbon ion RT

daily carbon ion radiotherapy

Intervention Type: RADIATION

Chemotherapy drug

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.

Intervention Type: DRUG

Eligibility Criteria

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 chest, abdomen, and pelvis within 30 days prior to registration
• ECOG Performance Status 0-1 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
• Hemoglobin ≥ 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable)
• Additional laboratory studies within 14 days prior to registration demonstrating:

Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)

• Bilirubin < 1.5 x ULN
• ALT and AST ≤ 2.5 x ULN
• aPTT, PT ≤ 1.5 x ULN
• Patients must provide study specific informed consent prior to study entry.
• 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.
• FOLFIRINOX
• Gemcitabine/nab-paclitaxel
• Gemcitabine
• S-1
• Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nitin Ohri, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Shanghai Proton and Heavy Ion Center (SPHIC)

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2020-11511

Identifier Type: -

Identifier Source: org_study_id