Previously Irradiated Recurrent Rectal CancerRECCPTNCT03098108
Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer
A study testing Concurrent chemo-proton therapy in people with Previously Irradiated Recurrent Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Previously Irradiated Recurrent Rectal Cancer
- What is being tested?
- Concurrent chemo-proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Feb 2017to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- previously diagnosed as rectal cancer and received curative intent treatment
- diagnosed as recurrent rectal cancer either pathology or radiologic exam
- discussed at tumor board and recommend proton therapy
- previous history of pelvic area radiotherapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- informed consent to present study
Show all 9Show fewer
- consent to contraception for 6 months during and after study participation
- maintained bone marrow function ( absolute neutrophil count ≥ 1,2 * 109/L, platelet count ≥ 100 * 109/L)
- maintained renal, hepatic function creatinine clearance ≥ 50 mL/minute total bilirubin ≥ 2.2 mg/dl alkaline phosphatase ≥ 192 U/L
Who cannot join
- Pregnant and/or breastfeeding woman
- Less than 12 weeks of expected survival
- Uncontrolled active co-morbidity
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Hee Cheol Kim, 82-2-3410-1655, hc111.kim@samsung.com
About this study
Official title: Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.
Read the detailed description
The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".
- Being tested
- Concurrent chemo-proton therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent chemo-proton therapyRadiation
Also called CCPT
Proton therapy with simultaneous integrated boost technique Gross tumor volume 70.4 gray (Gy)/ 16 fractions and clinical target volume 44.8 Gy/16 fractions Capecitabine twice a day 825 mg/body square meter
| Study group | Role | What they receive |
|---|---|---|
| CCPT | Experimental | Not described Receives: Radiation: Concurrent chemo-proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control rate at 3-year
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
Measured: 3-year after CCPT
Secondary outcomes (6)
adverse events
Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 3 months after CCPT
objective response rate
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
Measured: 1 and 3 months after CCPT
time to local tumor progression
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
Measured: 3-year after CCPT
progression free survival
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
Measured: 3-year after CCPT
Core Quality of life (QOL-C) assessment
QOL will be evaluated with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C) 30.
Measured: Baseline, at last week of CCPT, 1 and 3 months after CCPT
Colonrectum Quality of life (QOL-CR) assessment
QOL will be evaluated with EORTC QLQ- (colonrectum) CR 29.
Measured: Baseline, at last week of CCPT, 1 and 3 months after CCPT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start9 Feb 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously Irradiated Recurrent 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
- Model description
- CCPT arm
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Cheol Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098108
- Sponsor's protocol ID
- 2016-08-121
- Acronym
- RECCPT
- Status last verified
- Jun 2018
- First submitted
- 20 Feb 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT03098108
- Acronym / sponsor ID
- RECCPT / 2016-08-121
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.
Detailed description
The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CCPT arm
| Arm | Type | Receives |
|---|---|---|
| CCPT | Experimental | Radiation: Concurrent chemo-proton therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- previously diagnosed as rectal cancer and received curative intent treatment
- diagnosed as recurrent rectal cancer either pathology or radiologic exam
- discussed at tumor board and recommend proton therapy
- previous history of pelvic area radiotherapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
Key exclusion criteria (3 listed)
- Pregnant and/or breastfeeding woman
- Less than 12 weeks of expected survival
- Uncontrolled active co-morbidity
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 |
|---|---|---|
| Concurrent chemo-proton therapyAlso: CCPTProton therapy with simultaneous integrated boost technique Gross tumor volume 70.4 gray (Gy)/ 16 fractions and clinical target volume 44.8 Gy/16 fractions Capecitabine twice a day 825 mg/body square meter | Radiation | CCPT |
Primary outcome
local control rate at 3-year
Time frame: 3-year after CCPT
Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
6 secondary outcomes
adverse events
Time frame: 3 months after CCPT
objective response rate
Time frame: 1 and 3 months after CCPT
time to local tumor progression
Time frame: 3-year after CCPT
progression free survival
Time frame: 3-year after CCPT
Core Quality of life (QOL-C) assessment
Time frame: Baseline, at last week of CCPT, 1 and 3 months after CCPT
Colonrectum Quality of life (QOL-CR) assessment
Time frame: Baseline, at last week of CCPT, 1 and 3 months after CCPT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent chemo-proton therapy in people with Previously Irradiated Recurrent 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Cheol Kim (82-2-3410-1655, hc111.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control rate at 3-year (time frame: 3-year after CCPT). 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 28 Jun 2018.