Response to ToxinPhase 3NCT02484040
Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer
A Phase 3 study testing Two-week course of radiation in people with Response to Toxin and Toxicity, run by Jong Hoon Lee at 1 site in South Korea.
Trial summary
The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Response to Toxin, Toxicity, Recurrence
- What is being tested?
- Two-week course of radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Jul 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically confirmed adenocarcinoma;
- distal margin of the tumor located < 10 cm from the anal verge;
- cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
- no evidence of distant metastasis;
- Karnofsky performance score over 70;
- adequate bone marrow, liver, and renal function (leucocytes >4000/mm3, hemoglobin >10 g/dL, platelets >100,000/mm3; serum bilirubin <1.5 mg/dL, serum transaminase <2.5 times the upper normal limit; serum creatinine <1.5 mg/dL).
Who cannot join
- Metastatic disease
- No complete resection of tumor (R2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Lee Jong Hoon
Suwon
Jong Hoon Lee, koppul@catholic.ac.kr
About this study
Official title: Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial
The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
Read the detailed description
1.1 experimental arm Two-week course concurrent chemoradiotherapy
- Radiotherapy, 33 Gy/10 fractions for 2 weeks ↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12
- Capecitabine 825 mg/m2, twice daily
1.2 control arm
Standard concurrent chemoradiotherapy (CRT)
- Radiotherapy, 50.4 Gy/28 fractions for 6 weeks ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38
- Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5
- Capecitabine, 825 mg/ m2, bid
- Conditions
- Response to Toxin, Toxicity, Recurrence
- Being tested
- Two-week course of radiation
- Keywords
- tumor response, toxicity, recurrence, chemoradiotherpy, rectum
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-week course of radiationRadiation
Also called experimental arm
33 Gy in 10 fractions for 2 weeks
Two-week course of radiationDrug
Also called experimental arm
oral capecitabine, 825mg/m2, bid
| Study group | Role | What they receive |
|---|---|---|
| Two-week course arm | Experimental | Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine.
Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid Receives: Radiation: Two-week course of radiation; Drug: Two-week course of radiation |
| Conventional arm | No intervention | conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response from stage II-III to stage 0-I
Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)
Measured: from clinical staging time to radical surgery date (about 3 months)
Secondary outcomes (2)
Toxicity (acute and chronic)
During the course of radiotherapy, patients were evaluated weekly to assess acute toxicity. Patients were also followed 2 and 4 weeks after completion of radiotherapy and until 3 years after curative surgery to assess toxicity. Toxicity are assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Measured: from radiation start to 3 years after radical surgery
Recurrence and survival
Measured: 3-year recurrence-free survival and 3-year overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Response to ToxinStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jong Hoon Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jong Hoon Lee, Seoul St. Mary's Hospital
- Investigators
- Jong Hoon Lee, MD, Principal investigator, St. Vincent's Hospital, The Catholic University of Kora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484040
- Sponsor's protocol ID
- TwoArc trial
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2015
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.
PubMed 24411228
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02484040
- Acronym / sponsor ID
- TwoArc trial
- Conditions
- Response to Toxin, Toxicity, Recurrence
- Keywords
- tumor response, toxicity, recurrence, chemoradiotherpy, rectum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Jong Hoon LeeUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 29 Jun 2015 (estimated)
- 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 compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
Detailed description
1.1 experimental arm Two-week course concurrent chemoradiotherapy
- Radiotherapy, 33 Gy/10 fractions for 2 weeks ↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12
- Capecitabine 825 mg/m2, twice daily
1.2 control arm
Standard concurrent chemoradiotherapy (CRT)
- Radiotherapy, 50.4 Gy/28 fractions for 6 weeks ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38
- Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5
- Capecitabine, 825 mg/ m2, bid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-week course arm | Experimental | Radiation: Two-week course of radiation, Drug: Two-week course of radiationExperimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine. Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid |
| Conventional arm | No intervention | –conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed adenocarcinoma;
- distal margin of the tumor located < 10 cm from the anal verge;
- cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
- no evidence of distant metastasis;
- Karnofsky performance score over 70;
Key exclusion criteria (2 listed)
- Metastatic disease
- No complete resection of tumor (R2)
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 |
|---|---|---|
| Two-week course of radiationAlso: experimental arm33 Gy in 10 fractions for 2 weeks | Radiation | Two-week course arm |
| Two-week course of radiationAlso: experimental armoral capecitabine, 825mg/m2, bid | Drug | Two-week course arm |
Primary outcome
Tumor response from stage II-III to stage 0-I
Time frame: from clinical staging time to radical surgery date (about 3 months)
Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)
2 secondary outcomes
Toxicity (acute and chronic)
Time frame: from radiation start to 3 years after radical surgery
Recurrence and survival
Time frame: 3-year recurrence-free survival and 3-year overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Results publication: PubMed 24411228Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.
- Individual participant dataSharing planned: Yes
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.
Jong Hoon Lee, MD principal investigator
St. Vincent's Hospital, The Catholic University of Kora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Two-week course of radiation in people with Response to Toxin and Toxicity, run by Jong Hoon Lee 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 2 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 5 Jun 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jong Hoon Lee, MD (+82-031-249-8440, koppul@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response from stage II-III to stage 0-I (time frame: from clinical staging time to radical surgery date (about 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484040, which also lists 1 linked publication.
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 5 Jun 2017.