Phase I/II Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Recurrent Rectal Cancer
18 Years
N/A
Both
Recurrent Rectal Cancer
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,
respectively.
Type of Study:
Interventional
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:
Yes
Principal Investigator
Jürgen Debus, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Heidelberg
Authority:
Germany: Federal Office for Radiation Protection
Study ID:
PANDORA
NCT ID:
NCT01528683
Start Date:
December 2012
Completion Date:
December 2015
Related Keywords:
- Recurrent Rectal Cancer
- Rectal Neoplasms
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