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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)

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ClinicalTrials.gov Identifier: NCT03098108
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hee Cheol Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE February 20, 2017
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE February 9, 2017
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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.
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer
Official Title  ICMJE Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
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".
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
CCPT arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Previously Irradiated Recurrent Rectal Cancer
Intervention  ICMJE 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 Name: CCPT
Study Arms  ICMJE Experimental: CCPT
Intervention: Radiation: Concurrent chemo-proton therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hee Cheol Kim 82-2-3410-1655 hc111.kim@samsung.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098108
Other Study ID Numbers  ICMJE 2016-08-121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hee Cheol Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP