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

Not Applicable

• Conditions: Previously Irradiated Recurrent Rectal Cancer
• Interventions: Radiation: Concurrent chemo-proton therapy

• Registration Number: NCT03098108
• Lead Sponsor: Samsung Medical Center

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".

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-09
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28
• Primary Completion: 2019-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Pregnant and/or breastfeeding woman
• Less than 12 weeks of expected survival
• Uncontrolled active co-morbidity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCPT	Concurrent chemo-proton therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
adverse events	3 months after CCPT	Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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)
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.
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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of