CompletedPhase 1

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

United States, China14 participantsStarted 2016-04-01

Plain-language summary

This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Signed the informed consent form;
✓. Age ≥ 18;
✓. Capable of following the protocol
✓. Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
✓. Unresectable adenocarcinoma of the pancreas by radiographic criteria according to the criteria of the NCCN Guidelines and based on post-chemotherapy imaging or due to medical contraindications to radical resection;
✓. No evidence of distant metastases based on imaging evaluation;
✓. Maximum tumor and positive lymph node diameter ≤ 6 cm;
✓. ECOG Performance Status 0-1;

Exclusion criteria

✕. Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
✕. ECOG Performance Status \>=2;
✕. Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
✕. Persistent grade ≥ 2 toxicity due to previous cancer treatment;
✕. Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
✕. Those wearing a cardiac pacemaker or another type of metal prosthetic implant whose normal functions may suffer interference from high energy radiation or that could affect the radiation target area;
✕. Where it is not possible to achieve the predetermined safety dose limit with the dose equivalent limit of the organ at risk such as the liver or digestive tract, etc.;
✕. If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient;

What they're measuring

Dose-limiting toxicity

Timeframe: 90 days

Trial details

NCT IDNCT03403049

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-09

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