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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

February 20, 2017
March 31, 2017
June 28, 2018
February 9, 2017
October 31, 2019   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT03098108 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer
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.
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".
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Intervention Model Description:
CCPT arm
Masking: None (Open Label)
Primary Purpose: Treatment
Previously Irradiated Recurrent Rectal Cancer
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
Experimental: CCPT
Intervention: Radiation: Concurrent chemo-proton therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Same as current
October 31, 2021
October 31, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact: Hee Cheol Kim 82-2-3410-1655 hc111.kim@samsung.com
Korea, Republic of
 
 
NCT03098108
2016-08-121
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hee Cheol Kim, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
June 2018

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