Proton and Carbon Ion Radiotherapy for Locally Advanced Pancreatic Cancer

NCT03949933 | Completed DMC

• 1 other identifier: SPHIC-TR-PaCa2015-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for locally advanced pancreatic carcinoma (LAPC)

Conditions

Pancreatic Carcinoma

Keywords

proton and carbon ion radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Time interval from the start of radiotherapy to 3 months after the completion of radiotherapy

Secondary Outcomes (3)

• overall survival rate

  2 years

• local progression-free survival

  2 years

• progression-free survivals

  2 years

Study Arms (1)

proton and carbon ion radiotherapy

EXPERIMENTAL

proton and carbon ion radiotherapy

Radiation: proton and carbon ion radiotherapy

Interventions

proton and carbon ion radiotherapy RADIATION

proton and carbon ion radiotherapy

proton and carbon ion radiotherapy

Eligibility Criteria

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

You may qualify if:

• The histologically or cytologically confirmed, or the clinically diagnosed by clinical diagnosis criterion proposed by Pancreatic Cancer Committee of Chinese Anti-Cancer Association \[15\], which was based on evidences of (1). Typical symptoms of abdominal and/or back pain; (2). CA19-9 increased over the normal up limit; (3). A pancreatic mass shown on CT or MRI; and (4). SUV of PET-CT in mass increased compared to that in normal pancreas;
• Unresectable LAPC defined by the criteria of (NCCN) guidelines (Version 1. 2013), or refusal to surgery;
• Gastrointestinal tract (GI) not invaded;
• ECOG Performance Status 0-1 within 30 days prior to registration;
• Age of ≥ 18 years old;
• Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L);
• Enough liver and kidney functions (creatinine \<110gmol/L; urea nitrogen \<7.1mmol/L; bilirubin \< 1.5 x ULN, ALT and AST ≤ 2.5 x ULN);
• No evidence of distant metastases, based upon PET, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration;
• Informed consent form obtained.

You may not qualify if:

• No pathological evidence of malignant tumor;
• ECOG\>=2；
• Liver, kidney and bone marrow function are poor and not adequate for treatment;
• Side effect of previous treatment is not covered yet, eg. The interval between TACE and other anti-tumor therapy is less than one month;
• Prior radiation therapy to the abdomen or radioactive particle implantation;
• cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume;
• Dose constrain of normal liver, digested system and other OAR could not reach the expecting safe dose constrain;
• The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion;
• Comitant diseases or affecters which could affect the proton or heavy ion radiotherapy;
• Pregnancy（blood or urine β-HCG certified）or lactation;
• Drug or alcohol abused;
• HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage;
• HBV positive, hepatitis B virus replication stage, need to be treated with anti-virus treatment, but could not receive anti-virus treatment because of comitant disease;
• Psychiatric history, possibly affecting the completion of treatment;
• patients with serious complications that might affect radiotherapy， including 1）unstable angina pectoris requiring hospitalization in the last 6 months，congestive heart failure，myocardial infarction； 2）acute bacterial or systemic fungal infections； 3）exacerbation of chronic obstructive pulmonary disease ( COPD) or other respiratory system disease requiring hospitalization 4）hepatic function insufficiency or renal function insufficiency 5） immunosuppressed patients

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Protons; Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Radiotherapy; Therapeutics

Study Officials

• guoliang Jiang, Dr.

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of clinical technical committee, professor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 14, 2019
• Study Start: May 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)