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

Samsung Medical Center24 enrolled

Overview

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.

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".

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Previously Irradiated Recurrent Rectal Cancer

Interventions

Concurrent chemo-proton therapyRADIATION

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 3-year after CCPT

Secondary Outcomes

adverse events

Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: Baseline, at last week of CCPT, 1 and 3 months after CCPT

Central Contacts

Hee Cheol Kim

CONTACT

82-2-3410-1655 hc111.kim@samsung.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.