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

June 26, 2018 updated by: Hee Cheol Kim, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCPT
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
Other Names:
  • CCPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local control rate at 3-year
Time Frame: 3-year after CCPT
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
Time Frame: 3 months after CCPT
Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
3 months after CCPT
objective response rate
Time Frame: 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)
1 and 3 months after CCPT
time to local tumor progression
Time Frame: 3-year after CCPT
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
Time Frame: 3-year after CCPT
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
Time Frame: 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.
Baseline, at last week of CCPT, 1 and 3 months after CCPT
Colonrectum Quality of life (QOL-CR) assessment
Time Frame: Baseline, at last week of CCPT, 1 and 3 months after CCPT
QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29.
Baseline, at last week of CCPT, 1 and 3 months after CCPT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2017

Primary Completion (Anticipated)

October 31, 2019

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

March 27, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-08-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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