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slow accrual
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermo-radio-chemotherapy arm | Experimental | Hyperthermia with concurrent chemo-radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermia with concurrent chemo-radiation therapy | Radiation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Chul Park, Professor | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thermo-radio-chemotherapy Arm | Hyperthermia with concurrent chemo-radiation therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thermo-radio-chemotherapy Arm | Hyperthermia with concurrent chemo-radiation therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | age, categorical (years) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Curative Resection Rate of Laparoscopic TME | Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament | Posted | Count of Participants | Participants | expected average of 6 weeks after neoadjuvant treatement |
|
|
expected average of 16 weeks after neoadjuvant treatement
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thermo-radio-chemotherapy Arm | Hyperthermia with concurrent chemo-radiation therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | Samsung Medical Center | 82-2-3410-2612 | hee.ro.park@gmail.com |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| expected average of 6 weeks after neoadjuvant treatement |
| Count of Participants |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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) | 40% of pathologic response rate of laparoscopic TME after CCRT and hyperthermia treament | Posted | Number | participants | expected average of 6 weeks after neoadjuvant treatement |
|
|
|
| Primary | Adverse Event of Laparoscopic TME and Hyperthermia With CCRT | Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT | Posted | Count of Participants | Participants | expected average of 16 weeks after neoadjuvant treatement |
|
|
|
| Secondary | Rate of Open TME | Rate of open TME was measured as ten percent | Posted | Number | participants | expected average of 6 weeks after neoadjuvant treatement |
|
|
|
| Secondary | Pathologic Complete Response of Hyperthermia With CCRT | Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants | Posted | Number | participants | expected average of 6 weeks after neoadjuvant treatement |
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| 0 |
| 10 |
| 0 |
| 10 |
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