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

Not Applicable

Terminated

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Radiation: Hyperthermia with concurrent chemo-radiation therapy

• Registration Number: NCT02290574
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2018-09-04
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-13
• Last Update Submitted: 2019-10-13
• Results First Posted: 2019-11-01
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

• Extrapelvic metastasis
• Previous pelvic irradiation
• Current status of pregnant or breast feeding
• Confirmed other malignancy within two years except thyroid cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermo-radio-chemotherapy arm	Hyperthermia with concurrent chemo-radiation therapy	Hyperthermia with concurrent chemo-radiation therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of