Locally Advanced Rectal CancerNCT03676517
Evaluation of Efficacy, Quality of Life and Cost Effectiveness of Short-course Radiotherapy Followed by Capecitabine Plus Oxaliplatin chemotheRapy and TME for High-risk Rectal Cancer (ESCORT Trial)
A study testing preoperative short-course radiotherapy in people with Locally Advanced Rectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- preoperative short-course radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2019to Aug 2023
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection.
- If there is more than one, classify as a high risk group Positive CRM threatening: 5mm ≦ Extramural depth Positive EMVI.
- cN2: Positive Lateral pelvic LN metastasis
- Between 19 and 80 years of age;
- Satisfactory performance status: ECOG≦2
- American Society of Anesthesiologists (ASA) physical status classification system class I~III
- Adequate hematologic function: white blood cell(WBC) counts≥4,000/mm3, neutrophils counts ≥ 1,500/mm3, platelet counts ≥ 100,000/µL, hemoglobin ≥ 9g/L;
- Adequate renal function: creatinine ≤ 1.5×upper normal limit
Who cannot join
- The evidence of relapse of distant metastasis
- Receiving treatment of other anti-cancer drug or methods
- Patients have low compliance and are not able to complete the entire trial
- Presence of uncontrolled life-threatening diseases
- cT4 with infiltration of anterior organ on pretreatment MRI
- cT4 with infiltration of internal or external anal sphincter on pretreatment MRI
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, 03722
Min Soo Cho, MD, 82-2-2228-2107, nagase96@yuhs.ac
About this study
Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes even though some debates. Recently, Stockholm III trial comparing SCRT plus delayed surgery with SCRT plus immediate surgery and LCRT demonstrated no differences with respect to short-term outcomes such as complications, mortality, and acute toxicity. However, overall quality of life (QoL) after curative treatment for rectal cancer is still major concern in both SCRT and LCRT. Furthermore, daily hospital visits for 5 weeks may be the cause of the increase of total medical cost due to indirect medical expense in patients with LCRT, especially in rural area. SCRT plus chemotherapy followed by delayed surgery may have the possibility of reducing total hospital costs as well as increasing QoL by proving non-inferiority in terms of perioperative outcomes. The present prospective single-arm phase 2 trial was designed to validate the efficacy, quality of life and cost effectiveness of preoperative short-course radiotherapy plus XELOX chemotherapy followed by delayed surgery for high-risk rectal cancer patient based on magnetic resonance imaging.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- preoperative short-course radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative short-course radiotherapyRadiation
1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME)
| Study group | Role | What they receive |
|---|---|---|
| Preoperative short-course radiotherapy | Experimental | 1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME) Receives: Radiation: preoperative short-course radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (pCR) rate
According to pathological response criteria, a total regression is considered a complete response
Measured: Two weeks after surgery
Secondary outcomes (4)
Incidence of acute toxicities during radiation and chemotherapy
Incidence of acute toxicities during radiation and chemotherapy
Measured: Three months
Incidence of surgical complications
Incidence of surgical complications
Measured: Four weeks after surgery
Quality of life
QOL assessed using EORTC QLQ-CR29 survey form. The EORTC QLQ-CR29 is a 29-item colon and rectum cancer site-specific supplemental module that aims to enhance the sensitivity and specificity for colorectal cancer quality of life measures. The original English version comprises 4 multi-item scales (body image, urinary frequency, blood and mucus in stool, and stool frequency) and 17 functional/symptomatic single-items(anxiety, weight, sexual interest, urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problem, impotence or dyspareunia), with higher scores indicating better functional or worse symptomatic status. Of these 21 scales or items, only body image, anxiety, weight, and sexual interest are functional domain scales/items, and all the remaining are symptomatic.
Measured: Baseline and QOL at 8 weeks after radiotherapy
Cost effectiveness
QALYs (quality adjusted life years) with treatment protocol
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study startMar 2019 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (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 Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Enrolled patient receive 1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME). Short-term outcomes including complications, TME completeness, and tumor response will be investigated. EORTC-QLQ-C30 questionnaire scoring will be used to evaluate QoL during the treatment period and after surgery. Cost effectiveness will be assessed using cost-utility analysis.
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676517
- Sponsor's protocol ID
- 4-2018-0612
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JM, Lee J, Kim T, Kim NK, Cho MS. Long-Term Outcomes of Long-Course Chemoradiotherapy vs. Short-Course Radiotherapy Followed by Consolidation Chemotherapy in Rectal Cancer. Yonsei Med J. 2025 Dec;66(12):891-896. doi: 10.3349/ymj.2025.0216.
PubMed 41287502
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy, Quality of Life and Cost Effectiveness of Short-course Radiotherapy Followed by Capecitabine Plus Oxaliplatin chemotheRapy and TME for High-risk Rectal Cancer (ESCORT Trial)
- ClinicalTrials.gov ID
- NCT03676517
- Acronym / sponsor ID
- 4-2018-0612
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 18 Sep 2018 (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.
Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes even though some debates. Recently, Stockholm III trial comparing SCRT plus delayed surgery with SCRT plus immediate surgery and LCRT demonstrated no differences with respect to short-term outcomes such as complications, mortality, and acute toxicity. However, overall quality of life (QoL) after curative treatment for rectal cancer is still major concern in both SCRT and LCRT. Furthermore, daily hospital visits for 5 weeks may be the cause of the increase of total medical cost due to indirect medical expense in patients with LCRT, especially in rural area. SCRT plus chemotherapy followed by delayed surgery may have the possibility of reducing total hospital costs as well as increasing QoL by proving non-inferiority in terms of perioperative outcomes. The present prospective single-arm phase 2 trial was designed to validate the efficacy, quality of life and cost effectiveness of preoperative short-course radiotherapy plus XELOX chemotherapy followed by delayed surgery for high-risk rectal cancer patient based on magnetic resonance imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled patient receive 1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME). Short-term outcomes including complications, TME completeness, and tumor response will be investigated. EORTC-QLQ-C30 questionnaire scoring will be used to evaluate QoL during the treatment period and after surgery. Cost effectiveness will be assessed using cost-utility analysis.
| Arm | Type | Receives |
|---|---|---|
| Preoperative short-course radiotherapy | Experimental | Radiation: preoperative short-course radiotherapy1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- High-risk patients of rectal cancer on pretreatment MRI using the following risk stratification system Location of the lower part of the tumor is measured below less than 10 cm on the anal verge and lower part of the tumor is located below the lower limit of the peritoneal reflection.
- If there is more than one, classify as a high risk group Positive CRM threatening: 5mm ≦ Extramural depth Positive EMVI.
- cN2: Positive Lateral pelvic LN metastasis
- Between 19 and 80 years of age;
- Satisfactory performance status: ECOG≦2
Key exclusion criteria (6 listed)
- The evidence of relapse of distant metastasis
- Receiving treatment of other anti-cancer drug or methods
- Patients have low compliance and are not able to complete the entire trial
- Presence of uncontrolled life-threatening diseases
- cT4 with infiltration of anterior organ on pretreatment MRI
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 |
|---|---|---|
| preoperative short-course radiotherapy1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME) | Radiation | Preoperative short-course radiotherapy |
Primary outcome
pathologic complete response (pCR) rate
Time frame: Two weeks after surgery
According to pathological response criteria, a total regression is considered a complete response
4 secondary outcomes
Incidence of acute toxicities during radiation and chemotherapy
Time frame: Three months
Incidence of surgical complications
Time frame: Four weeks after surgery
Quality of life
Time frame: Baseline and QOL at 8 weeks after radiotherapy
Cost effectiveness
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 41287502Lee JM, Lee J, Kim T, Kim NK, Cho MS. Long-Term Outcomes of Long-Course Chemoradiotherapy vs. Short-Course Radiotherapy Followed by Consolidation Chemotherapy in Rectal Cancer. Yonsei Med J. 2025 Dec;66(12):891-896. doi: 10.3349/ymj.2025.0216.
Related trials for Locally Advanced Rectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Not yet recruitingPhase 3
Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative short-course radiotherapy in people with Locally Advanced Rectal Cancer, run by Yonsei University 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 8 inclusion and 6 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 15 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Soo Cho, MD (82-2-2228-2107, nagase96@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (pCR) rate (time frame: Two weeks after surgery). 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 NCT03676517, 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 15 Feb 2019.