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

Previously Irradiated Recurrent Rectal Cancer Clinical Trial

— RECCPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03098108
• Other study ID #: 2016-08-121
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2018
• Source: Samsung Medical Center
• Contact: Hee Cheol Kim
• Phone: 82-2-3410-1655
• Email: hc111.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Previously Irradiated Recurrent Rectal Cancer
• Rectal Neoplasms
• Recurrence

Intervention

Radiation:
• Concurrent 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse events	Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	3 months after CCPT
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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