Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery

NCT05830019 | Unknown DMC

• 1 other identifier: SPHIC-TR-PaCa2021-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for recurrent pancreatic carcinoma post surgery

Conditions

Pancreatic Carcinoma

Keywords

carbon ion radiotherapy; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• local progression-free survival

  local progression-free survival

  2 years

Secondary Outcomes (3)

• overall survival rate

  2 years

• progression-free survival

  2 years

• adverse events

  3 years

Study Arms (1)

carbon ion radiotherapy

EXPERIMENTAL

carbon ion radiotherapy

Radiation: carbon ion radiotherapy

Interventions

carbon ion radiotherapy RADIATION

carbon ion radiotherapy

carbon ion radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The histologically or cytologically confirmed pancreatic adenocarcinoma;
• Local-regional recurrent pancreatic cancer post surgery, no evidence of distant metastases, based upon Positron Emission Tomography, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration;
• Eastern Cooperative Oncology Group 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, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN);
• Informed consent form obtained.

You may not qualify if:

• Eastern Cooperative Oncology Group Performance Status \>=2；
• Liver, kidney and bone marrow function are poor and not adequate for treatment;
• GI was invaded by recurrent lesions;
• Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions;
• 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 organ at risk 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 which could affect the proton or heavy ion radiotherapy;
• Pregnancy（blood or urine β-human chorionic gonadotropin 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;
• hepatitis B virus 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
• patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

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)

Radiotherapy; Therapeutics

Study Officials

• Guoliang Jiang, Dr.

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Cai, Dr.

CONTACT

+862138296666; xin.cai@sphic.org.cn

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: November 21, 2021
• First Posted: April 26, 2023
• Study Start: June 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)