Locally Advanced Rectal Cancer
Conditions
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.
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.
Interventions
RADIATIONHyperthermia with concurrent chemo-radiation therapy
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Curative Resection Rate of Laparoscopic TME | expected average of 6 weeks after neoadjuvant treatement | Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament |
| Pathologic Response of Thermo-radio-chemotherapy | 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) |
| Adverse Event of Laparoscopic TME and Hyperthermia With CCRT | expected average of 16 weeks after neoadjuvant treatement | Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Open TME | expected average of 6 weeks after neoadjuvant treatement | Rate of open TME was measured as ten percent |
| Pathologic Complete Response of Hyperthermia With CCRT | expected average of 6 weeks after neoadjuvant treatement | Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thermo-radio-chemotherapy Arm Hyperthermia with concurrent chemo-radiation therapy | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Thermo-radio-chemotherapy Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 60 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment South Korea | 14 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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
Time frame: expected average of 16 weeks after neoadjuvant treatement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermo-radio-chemotherapy Arm | Adverse Event of Laparoscopic TME and Hyperthermia With CCRT | 0 Participants |
Primary
Curative Resection Rate of Laparoscopic TME
Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament
Time frame: expected average of 6 weeks after neoadjuvant treatement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thermo-radio-chemotherapy Arm | Curative Resection Rate of Laparoscopic TME | 9 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)
Time frame: expected average of 6 weeks after neoadjuvant treatement
Population: 40% of pathologic response rate of laparoscopic TME after CCRT and hyperthermia treament
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thermo-radio-chemotherapy Arm | Pathologic Response of Thermo-radio-chemotherapy | 4 participants |
Secondary
Pathologic Complete Response of Hyperthermia With CCRT
Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants
Time frame: expected average of 6 weeks after neoadjuvant treatement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thermo-radio-chemotherapy Arm | Pathologic Complete Response of Hyperthermia With CCRT | 2 participants |
Secondary
Rate of Open TME
Rate of open TME was measured as ten percent
Time frame: expected average of 6 weeks after neoadjuvant treatement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thermo-radio-chemotherapy Arm | Rate of Open TME | 1 participants |