Carbon Ion RT for Locally Advanced Pancreatic Cancer

NCT04592861 | Terminated Phase 3 DMC

• 1 other identifier: 2020-11511
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

pancreatic cancer; carbon ion

Outcome Measures

Primary Outcomes (1)

• Overall survival duration

  The length of time from randomization of treatment for cancer, that patients diagnosed with the disease are still alive.

  The length of time from randomization until death from any cause for up to 24 months

Secondary Outcomes (4)

• Progression-free survival duration

  he length of time from study registration until disease progression at any site or death from any cause, up to 24 months

• Local disease progression scored using RECIST 1.1 criteria

  Up to 24 months

• Adverse events as defined by CTCAE v5.0

  Up to 24 months

• Quality-of-life, measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaire

  up to 24 months

Study Arms (2)

Carbon ion radiotherapy

EXPERIMENTAL

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.

Radiation: carbon ion RT; Drug: Chemotherapy drug

Routine standard of care

ACTIVE COMPARATOR

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

Drug: Chemotherapy drug

Interventions

carbon ion RT RADIATION

daily carbon ion radiotherapy

Carbon ion radiotherapy

Chemotherapy drug 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.

Carbon ion radiotherapy; Routine standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Shanghai Proton and Heavy Ion Center: collaborator

Study Sites (1)

Shanghai Proton and Heavy Ion Center (SPHIC)

Shanghai, Shanghai Municipality, 201315, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Nitin Ohri, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)