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Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial (NEOTREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290574
Recruitment Status : Terminated (slow accrual)
First Posted : November 14, 2014
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Park Hee Chul, Samsung Medical Center

Brief Summary:
The investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.

Condition or disease Intervention/treatment Phase
Locally Advanced Rectal Cancer Radiation: Hyperthermia with concurrent chemo-radiation therapy Not Applicable

Detailed Description:

The current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent chemo-radiation therapy (CCRT) followed by total mesorectal excision (TME). Recently, laparoscopic surgery is getting substitute open surgery based on the advantages of early recovery, short admission, less pain, less blood loss, and little scar without compromising oncologic outcomes.

It is reported that hyperthermia is effective in synthetic (S) phase, Low oxgen pressure, acidic, and low perfusion site which are known as radio-resistant. Because of these characteristics, it considered as the most valuable radiosensitizer in cancer treatment, theoretically. Furthermore, mild hyperthermia (41 to 41.5 ºC) can promote tumor reoxygenation.

Based on those background, the investigators start this prospective study to evaluate the efficacy of laparoscopic TME after CCRT with hyperthermia in locally advanced rectal cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Thermo-radio-chemotherapy arm
Hyperthermia with concurrent chemo-radiation therapy
Radiation: Hyperthermia with concurrent chemo-radiation therapy



Primary Outcome Measures :
  1. Curative Resection Rate of Laparoscopic TME [ Time Frame: expected average of 6 weeks after neoadjuvant treatement ]
    Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament

  2. Pathologic Response of Thermo-radio-chemotherapy [ Time Frame: expected average of 6 weeks after neoadjuvant treatement ]
    The pathologic response was assessed according to the Dworak's system. The pathologic response grades were as follows: grade 0, no response; grade 1, dominant tumor mass with obvious fibrosis, vasculopathy, or both (minimal response); grade 2, dominant fibrotic changes with a few easy-to-find tumor cells or groups (moderate response); grade 3, few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance (near complete response); and grade 4, no viable tumor (complete response)

  3. Adverse Event of Laparoscopic TME and Hyperthermia With CCRT [ Time Frame: expected average of 16 weeks after neoadjuvant treatement ]
    Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT


Secondary Outcome Measures :
  1. Rate of Open TME [ Time Frame: expected average of 6 weeks after neoadjuvant treatement ]
    Rate of open TME was measured as ten percent

  2. Pathologic Complete Response of Hyperthermia With CCRT [ Time Frame: expected average of 6 weeks after neoadjuvant treatement ]
    Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants



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

Inclusion Criteria:

  • 20 years or older
  • pathologically confirmed rectal cancer
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Candidate of laparoscopic TME
  • Optimal bone marrow function
  • Locally advanced rectal cancer confirmed by magnetic resonance imaging

Exclusion Criteria:

  • Extrapelvic metastasis
  • Previous pelvic irradiation
  • Current status of pregnant or breast feeding
  • Confirmed other malignancy within two years except thyroid cancer

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): NCT02290574


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Hee Chul Park, Professor Samsung Medical Center, Sungkyunkwan University School of Medicine
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Responsible Party: Park Hee Chul, Assocate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02290574    
Other Study ID Numbers: 2014-10-019
First Posted: November 14, 2014    Key Record Dates
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases