Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2025-02-10

Brief Summary

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Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

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Detailed Description

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Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.

Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.

Conditions

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Cancer of Pancreas Pancreas Adenocarcinoma Resectable Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperatory chemoradiation therapy with carbon ions

Chemoradiation followed by surgery

Group Type EXPERIMENTAL

Preoperative chemotherapy

Intervention Type DRUG

Preoperative chemotherapy, carbon ion therapy, surgery

Preoperative radiotherapy

Intervention Type RADIATION

Preoperative chemotherapy, carbon ion therapy, surgery

Interventions

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Preoperative chemotherapy

Preoperative chemotherapy, carbon ion therapy, surgery

Intervention Type DRUG

Preoperative radiotherapy

Preoperative chemotherapy, carbon ion therapy, surgery

Intervention Type RADIATION

Other Intervention Names

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Folinic acid, Irinotecan, fluorouracil, oxaliplatin Carbon ion therapy

Eligibility Criteria

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Inclusion Criteria

* histologic/cytologic diagnosis of exocrine pancreas tumour
* resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
* no metastasis from US, CT, PET, MRI or laparotomy
* Karnofsky index \>= 70
* stomach and duodenum not infiltrated by tumour
* given informed consent to study procedures
* Hb \> 9 g/dL, N\> 1500, PLT\> 100000
* creatininemia \< 1.5 mg/dL; bilirubinemia \< 1.5 times upper normal values; albumin \> 3 g/dL
* DPD normal activity
* contraception required and breast feeding not permitted

Exclusion Criteria

* non resectable, locally advanced tumours
* insular cells tumour
* comorbidities excluding abdominal surgery and/or chemo- radiation therapy
* known metastasis
* DPD low activity
* inability to attend study procedures and follow ups
* pregnancy
* previous diagnosis of other tumour with more disadvantageous prognosis then the study object
* metallic biliary stent
* metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
* clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
* medical and/or psychical condition preventing from radiation therapy
* past radiation therapy on abdomen.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No