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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial

Conditions
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Locally Advanced Rectal Cancer

Intervention / Treatment
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* Radiation: Hyperthermia with concurrent chemo-radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermo-radio-chemotherapy arm<br>Hyperthermia with concurrent chemo-radiation therapy | Radiation: Hyperthermia with concurrent chemo-radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curative Resection Rate of Laparoscopic TME | Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament | expected average of 6 weeks after neoadjuvant treatement | 
| Pathologic Response of Thermo-radio-chemotherapy | 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) | expected average of 6 weeks after neoadjuvant treatement | 
| Adverse Event of Laparoscopic TME and Hyperthermia With CCRT | Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT | expected average of 16 weeks after neoadjuvant treatement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Open TME | Rate of open TME was measured as ten percent | expected average of 6 weeks after neoadjuvant treatement | 
| Pathologic Complete Response of Hyperthermia With CCRT | Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants | expected average of 6 weeks after neoadjuvant treatement |