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

May 11, 2018 updated by: Juergen Debus, University Hospital Heidelberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • University Hospital of Heidelberg, Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Carbon Ion Radiotherapy
Radiation: Carbon Ion Radiotherapy
Treatment with carbon ion radiotherapy using the rasterscanning technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Efficacy
Time Frame: 3 months

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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Investigators

  • Principal Investigator: Jürgen Debus, MD PhD, University Hospital of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2012

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

December 31, 2011

First Submitted That Met QC Criteria

February 7, 2012

First Posted (ESTIMATE)

February 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDORA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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