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

Locally Advanced Rectal Cancer Clinical Trial

— NEOTREAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02290574
• Other study ID #: 2014-10-019
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Hyperthermia with concurrent chemo-radiation therapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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)	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	expected average of 16 weeks after neoadjuvant treatement
Secondary	Rate of Open TME	Rate of open TME was measured as ten percent	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	expected average of 6 weeks after neoadjuvant treatement