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

Primary Purpose

Previously Irradiated Recurrent Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Concurrent chemo-proton therapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Previously Irradiated Recurrent Rectal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CCPT

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

adverse events
Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
objective response rate
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
time to local tumor progression
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
progression free survival
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
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.
Colonrectum Quality of life (QOL-CR) assessment
QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29.

Full Information

First Posted
February 20, 2017
Last Updated
June 26, 2018
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03098108
Brief Title
Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previously Irradiated Recurrent Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
CCPT arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCPT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Concurrent chemo-proton therapy
Other Intervention Name(s)
CCPT
Intervention Description
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
Primary Outcome Measure Information:
Title
local control rate at 3-year
Description
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 Outcome Measure Information:
Title
adverse events
Description
Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame
3 months after CCPT
Title
objective response rate
Description
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
Title
time to local tumor progression
Description
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
Title
progression free survival
Description
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
Title
Core Quality of life (QOL-C) assessment
Description
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
Title
Colonrectum Quality of life (QOL-CR) assessment
Description
QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29.
Time Frame
Baseline, at last week of CCPT, 1 and 3 months after CCPT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Cheol Kim
Phone
82-2-3410-1655
Email
hc111.kim@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Cheol Kim
Phone
82-2-3410-1655
Email
hc111.kim@samsung.com

12. IPD Sharing Statement

Learn more about this trial

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

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