Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an effective treatment for liver cancer.

PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam radiation therapy in treating patients with liver cancer that cannot be removed by surgery.

Conditions

• Liver Cancer

Interventions

RADIATION

3-dimensional conformal radiation therapy

Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed. Phase I: Dose finding according to the following escalation table: Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week) 1. (3 patients) 27 x 2 Gy = 54 Gy 2. (3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy 3. (3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy 4. (5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy 5. (5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed.

RADIATION

intensity-modulated radiation therapy

Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed. Phase I: Dose finding according to the following escalation table: Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week) 1. (3 patients) 27 x 2 Gy = 54 Gy 2. (3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy 3. (3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy 4. (5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy 5. (5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed.

RADIATION

stereotactic body radiation therapy

Once daily RT sessions with 2 Gy, five days a week (on weekdays), will be performed. Phase I: Dose finding according to the following escalation table: Dose level Radiotherapy dose (1 x 2 Gy session/day, 5 sessions/week) 1. (3 patients) 27 x 2 Gy = 54 Gy 2. (3 patients) 29 x 2 Gy = 58 Gy, with optional field reduction after a dose of 54 Gy 3. (3 patients) 31 x 2 Gy = 62 Gy, with optional field reduction after a dose of 54 Gy 4. (5 patients) 33 x 2 Gy = 66 Gy, with optional field reduction after a dose of 54 Gy 5. (5 patients) 35 x 2 Gy = 70 Gy, with optional field reduction after a dose of 54 Gy Phase II: The dose for phase II will be recommended according to the MTD determined in phase I, if the MTD is 62 Gy or higher. If the MTD is 58 Gy or lower, the phase II part of the trial will not be performed.

Sponsors & Collaborators

• Swiss Cancer Institute

  lead OTHER

Principal Investigators

• Diana Naehrig, MD · Unviersitaetsspital Basel

• Ilja Frank Ciernik, MD · Städtisches Klinikum Dessau

• Daniel Aebersold, MD · Insel Gruppe AG, University Hospital Bern

• Jean-Francois Dufour, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2014-01-31

Completion

2015-12-31

Countries

• Netherlands
• Switzerland

Study Locations