Trial Outcomes & Findings for Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial (NCT NCT02290574)

Results Overview

Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

expected average of 6 weeks after neoadjuvant treatement

Results posted on

2019-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Thermo-radio-chemotherapy Arm Hyperthermia with concurrent chemo-radiation therapy
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thermo-radio-chemotherapy Arm n=14 Participants Hyperthermia with concurrent chemo-radiation therapy
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=14 Participants
Age, Categorical >=65 years	6 Participants n=14 Participants
Age, Continuous	60 years n=14 Participants
Sex: Female, Male Female	4 Participants n=14 Participants
Sex: Female, Male Male	10 Participants n=14 Participants
Region of Enrollment South Korea	14 participants n=14 Participants

PRIMARY outcome

Timeframe: expected average of 6 weeks after neoadjuvant treatement

Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament

Outcome measures

Outcome measures
Measure	Thermo-radio-chemotherapy Arm n=10 Participants Hyperthermia with concurrent chemo-radiation therapy
Curative Resection Rate of Laparoscopic TME	9 Participants

PRIMARY outcome

Timeframe: expected average of 6 weeks after neoadjuvant treatement

Population: 40% of pathologic response rate of laparoscopic TME after CCRT and hyperthermia treament

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)

Outcome measures

Outcome measures
Measure	Thermo-radio-chemotherapy Arm n=10 Participants Hyperthermia with concurrent chemo-radiation therapy
Pathologic Response of Thermo-radio-chemotherapy	4 participants

PRIMARY outcome

Timeframe: expected average of 16 weeks after neoadjuvant treatement

Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT

Outcome measures

Outcome measures
Measure	Thermo-radio-chemotherapy Arm n=10 Participants Hyperthermia with concurrent chemo-radiation therapy
Adverse Event of Laparoscopic TME and Hyperthermia With CCRT	0 Participants

SECONDARY outcome

Timeframe: expected average of 6 weeks after neoadjuvant treatement

Rate of open TME was measured as ten percent

Outcome measures

Outcome measures
Measure	Thermo-radio-chemotherapy Arm n=10 Participants Hyperthermia with concurrent chemo-radiation therapy
Rate of Open TME	1 participants

SECONDARY outcome

Timeframe: expected average of 6 weeks after neoadjuvant treatement

Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants

Outcome measures

Outcome measures
Measure	Thermo-radio-chemotherapy Arm n=10 Participants Hyperthermia with concurrent chemo-radiation therapy
Pathologic Complete Response of Hyperthermia With CCRT	2 participants

Adverse Events

Thermo-radio-chemotherapy Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor

Samsung Medical Center

Phone: 82-2-3410-2612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place