Previously Irradiated Recurrent Rectal Cancer
Conditions
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.
Interventions
RADIATIONConcurrent chemo-proton therapy
Proton therapy with simultaneous integrated boost technique Gross tumor volume 70.4 gray (Gy)/ 16 fractions and clinical target volume 44.8 Gy/16 fractions Capecitabine twice a day 825 mg/body square meter
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CCPT arm
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local control rate at 3-year | 3-year after CCPT | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 1 and 3 months after CCPT | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) |
| time to local tumor progression | 3-year after CCPT | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) |
| adverse events | 3 months after CCPT | Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
| Core Quality of life (QOL-C) assessment | Baseline, at last week of CCPT, 1 and 3 months after CCPT | QOL will be evaluated with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C) 30. |
| Colonrectum Quality of life (QOL-CR) assessment | Baseline, at last week of CCPT, 1 and 3 months after CCPT | QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29. |
| progression free survival | 3-year after CCPT | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) |
Countries
South Korea
Contacts
Primary ContactHee Cheol Kim
Outcome results
None listed