Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial

Conditions
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Previously Irradiated Recurrent Rectal Cancer

Intervention / Treatment
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* Radiation: Concurrent chemo-proton therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: CCPT arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCPT<br> | Radiation: Concurrent chemo-proton therapy<br>* 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<br>* Other names: CCPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control rate at 3-year | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 3-year after CCPT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | 3 months after CCPT | 
| objective response rate | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 1 and 3 months after CCPT | 
| time to local tumor progression | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 3-year after CCPT | 
| progression free survival | Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1) | 3-year after CCPT | 
| Core Quality of life (QOL-C) assessment | QOL will be evaluated with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C) 30. | Baseline, at last week of CCPT, 1 and 3 months after CCPT | 
| Colonrectum Quality of life (QOL-CR) assessment | QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29. | Baseline, at last week of CCPT, 1 and 3 months after CCPT |