Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Previously Irradiated Recurrent Rectal Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- local control rate at 3-year
- Last Updated
- 7 years ago
Overview
Brief Summary
The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.
Detailed Description
The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".
Investigators
Hee Cheol Kim
Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •previously diagnosed as rectal cancer and received curative intent treatment
- •diagnosed as recurrent rectal cancer either pathology or radiologic exam
- •discussed at tumor board and recommend proton therapy
- •previous history of pelvic area radiotherapy
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •informed consent to present study
- •consent to contraception for 6 months during and after study participation
- •maintained bone marrow function ( absolute neutrophil count ≥ 1,2 \* 109/L, platelet count ≥ 100 \* 109/L)
- •maintained renal, hepatic function creatinine clearance ≥ 50 mL/minute total bilirubin ≥ 2.2 mg/dl alkaline phosphatase ≥ 192 U/L
Exclusion Criteria
- •Pregnant and/or breastfeeding woman
- •Less than 12 weeks of expected survival
- •Uncontrolled active co-morbidity
Outcomes
Primary Outcomes
local control rate at 3-year
Time Frame: 3-year after CCPT
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
Secondary Outcomes
- Core Quality of life (QOL-C) assessment(Baseline, at last week of CCPT, 1 and 3 months after CCPT)
- progression free survival(3-year after CCPT)
- adverse events(3 months after CCPT)
- objective response rate(1 and 3 months after CCPT)
- time to local tumor progression(3-year after CCPT)
- Colonrectum Quality of life (QOL-CR) assessment(Baseline, at last week of CCPT, 1 and 3 months after CCPT)