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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 : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hee Cheol Kim, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Previously Irradiated Recurrent Rectal Cancer Radiation: Concurrent chemo-proton therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: CCPT arm
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2021

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 Name: CCPT



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098108


Contacts
Contact: Hee Cheol Kim 82-2-3410-1655 hc111.kim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Souol, Korea, Republic of, 06351
Contact: Hee Cheol Kim    82-2-3410-1655    hc111.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Hee Cheol Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03098108     History of Changes
Other Study ID Numbers: 2016-08-121
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rectal Neoplasms
Recurrence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes