Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer (PANDORA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Stephanie Combs, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01528683
First received: December 31, 2011
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Rectal Cancer
Radiation: Carbon Ion Radiotherapy
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 45
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)
Arms Assigned Interventions
Experimental: Carbon Ion Radiotherapy Radiation: Carbon Ion Radiotherapy
Treatment with carbon ion radiotherapy using the rasterscanning technique

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Locally recurrent rectal cancer
  • Inoperable lesion
  • Macroscopic tumor up to 1000ml volume- prior photon radiation of 20-60 Gy
  • time between initial radiotherapy and re-irradiation of at least 12 months
  • age ≥ 18 years of age
  • Karnofsky Performance Score >60
  • For women with childbearing potential, (and men) adequate contraception.
  • Ability of subject to understand character and individual consequences of the clinical trial
  • Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

  • refusal of the patients to take part in the study
  • advanced metastatic disease
  • Patients who have not yet recovered from acute toxicities of prior therapies
  • Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy- Pregnant or lactating women
  • Participation in another clinical study or observation period of competing trials, respectively.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528683

Contacts
Contact: Stephanie E Combs, MD +49-6221-56-8202 stephanie.combs@med.uni-heidelberg.de
Contact: Jürgen Debus, MD PHd +49-6221-56-8202 juergen.debus@med.uni-heidelberg.de

Locations
Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany
Contact: Stephanie E Combs, MD    +49-6221-56-8202    stephanie.combs@med.uni-heidelberg.de   
Contact: Jürgen Debus, MD PhD    +49-6221-56-8202    juergen.debus@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Jürgen Debus, MD PhD University Hospital of Heidelberg
  More Information

No publications provided

Responsible Party: Stephanie Combs, Leitende Oberärztin, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01528683     History of Changes
Other Study ID Numbers: PANDORA
Study First Received: December 31, 2011
Last Updated: February 18, 2013
Health Authority: Germany: Federal Office for Radiation Protection

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014