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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Recurrent Rectal Cancer

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Trial Information

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

Inclusion 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,

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Efficacy

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Jürgen Debus, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Heidelberg


Germany: Federal Office for Radiation Protection

Study ID:




Start Date:

December 2012

Completion Date:

December 2015

Related Keywords:

  • Recurrent Rectal Cancer
  • Rectal Neoplasms