Locally Advanced Rectal CancerNEOTREATNCT02290574
Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial
A study testing Hyperthermia with concurrent chemo-radiation therapy in people with Locally Advanced Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Hyperthermia with concurrent chemo-radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Extrapelvic metastasis
- Previous pelvic irradiation
- Current status of pregnant or breast feeding
- Confirmed other malignancy within two years except thyroid cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial
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.
Read the 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.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Hyperthermia with concurrent chemo-radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia with concurrent chemo-radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Thermo-radio-chemotherapy arm | Experimental | Hyperthermia with concurrent chemo-radiation therapy Receives: Radiation: Hyperthermia with concurrent chemo-radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curative Resection Rate of Laparoscopic TME
Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament
Measured: 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)
Measured: 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
Measured: expected average of 16 weeks after neoadjuvant treatement
Secondary outcomes (2)
Rate of Open TME
Rate of open TME was measured as ten percent
Measured: 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
Measured: expected average of 6 weeks after neoadjuvant treatement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park Hee Chul, Samsung Medical Center
- Investigators
- Hee Chul Park, Professor, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290574
- Sponsor's protocol ID
- 2014-10-019
- Acronym
- NEOTREAT
- Status last verified
- Oct 2019
- First submitted
- 6 Nov 2014
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT02290574
- Acronym / sponsor ID
- NEOTREAT / 2014-10-019
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermo-radio-chemotherapy arm | Experimental | Radiation: Hyperthermia with concurrent chemo-radiation therapyHyperthermia with concurrent chemo-radiation therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Extrapelvic metastasis
- Previous pelvic irradiation
- Current status of pregnant or breast feeding
- Confirmed other malignancy within two years except thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermia with concurrent chemo-radiation therapy | Radiation | Thermo-radio-chemotherapy arm |
Primary outcome
Curative Resection Rate of Laparoscopic TME
Time frame: 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
Time frame: 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
Time frame: expected average of 16 weeks after neoadjuvant treatement
Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT
2 secondary outcomes
Rate of Open TME
Time frame: expected average of 6 weeks after neoadjuvant treatement
Pathologic Complete Response of Hyperthermia With CCRT
Time frame: expected average of 6 weeks after neoadjuvant treatement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Locally Advanced Rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Chul Park, Professor study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia with concurrent chemo-radiation therapy in people with Locally Advanced Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curative Resection Rate of Laparoscopic TME (time frame: expected average of 6 weeks after neoadjuvant treatement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.