Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer (PANDORA)
Treatment standard for patients with rectal cancer depends on the initial staging and includes surgical resection, radiotherapy as well as chemotherapy. For stage II and III tumors, radiochemotherapy should be performed in addition to surgery, preferentially as preoperative radiochemotherapy or as short-course hypofractionated radiation. Advances in surgical approaches, especially the establishment of the total mesorectal excision (TME) in combination with sophisticated radiation and chemotherapy have reduced local recurrence rates to only few percent. However, due to the high incidence of rectal cancer, still a high absolute number of patients present with recurrent rectal carcinomas, and effective treatment is therefore needed.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
Japanese data on the treatment of patients with recurrent rectal cancer previously not treated with radiation therapy have shown local control rates of carbon ion treatment superior to those of surgery. Therefore, this treatment concept should also be evaluated for recurrences after radiotherapy, when dose application using conventional photons is limited. Moreover, these patients are likely to benefit from the enhanced biological efficacy of carbon ions.
In the current Phase I/II-PANDORA-01-Study the recommended dose of carbon ion radiotherapy for recurrent rectal cancer will be determined in the Phase I part, and feasibility and progression-free survival will be assessed in the Phase II part of the study.
Within the Phase I part, increasing doses from 12 x 3 Gy E to 18 x 3 Gy E will be applied.
The primary endpoint in the Phase I part is toxicity, the primary endpoint in the Phase II part its progression-free survival.
Recurrent Rectal Cancer
Radiation: Carbon Ion Radiotherapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer|
- Safety and Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Phase I part:
The primary endpoint is toxicity measured by any Grade IV toxicity related to the study treatment according to CTCAE Grade 41. A maximum of 45 patients are projected for the Phase I part of the study. Patients will be followed for at least 3 months after study treatment to document any toxicity according to CTCAE Version 4.0.
Phase II part:
The primary endpoint is progression-free survival after re-irradiation at 12 months, therefore patients are followed within the trial protocol for a minimum 12 months after completion of study treatment.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: Carbon Ion Radiotherapy||
Radiation: Carbon Ion Radiotherapy
Treatment with carbon ion radiotherapy using the rasterscanning technique
|Contact: Stephanie E Combs, MDfirstname.lastname@example.org|
|Contact: Jürgen Debus, MD PHdemail@example.com|
|University Hospital of Heidelberg, Radiation Oncology||Recruiting|
|Contact: Stephanie E Combs, MD +49-6221-56-8202 firstname.lastname@example.org|
|Contact: Jürgen Debus, MD PhD +49-6221-56-8202 email@example.com|
|Principal Investigator:||Jürgen Debus, MD PhD||University Hospital of Heidelberg|