Rectal CancerPhase 2NCT04664504
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
A Phase 2 study testing Concurrent Chemoradiotherapy Radiotherapy, Short-course Radiotherapy and Local dose increase of Short-course Radiotherapy in people with Rectal Cancer, run by Jing Jin, M.D. at 1 site in China.
Trial summary
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Concurrent Chemoradiotherapy Radiotherapy, Short-course Radiotherapy and Local dose increase of Short-course Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal adenocarcinoma confirmed by histopathology
- MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
- The age is 18-75 years old, no gender limit
- 3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
Who cannot join
- History of other malignant tumors;
- They were allergic to 5-FU, platinum, etc;
- The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
- After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
- History of gastrointestinal fistula, perforation or severe ulcer;
- At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100021
Yuan Tang, MD, 0086-15011304945, tangyuan82@162.com
About this study
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Read the detailed description
For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.
- Conditions
- Rectal Cancer
- Being tested
- Concurrent Chemoradiotherapy Radiotherapy, Short-course Radiotherapy, Local dose increase of Short-course Radiotherapy, Consolidation chemotherapy, Adjuvant chemotherapy
- Keywords
- Rectal Cancer, Neoadjuvant Chemoradiotherapy, Recurrence Risk
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Chemoradiotherapy RadiotherapyCombination product
Also called CRT
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
Short-course RadiotherapyRadiation
Also called SCRT
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Local dose increase of Short-course RadiotherapyRadiation
Also called es-SCRT
25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Consolidation chemotherapyDrug
Also called XEOLX*4 courses
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course.
Adjuvant chemotherapyDrug
Also called XEOLX*6 courses
2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses*3 weeks per course
TMEProcedure or surgery
Total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Group CRT | Active comparator | concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group) Receives: Combination Product: Concurrent Chemoradiotherapy Radiotherapy; Drug: Adjuvant chemotherapy; Procedure: TME |
| Group SCRT | Experimental | Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) Receives: Radiation: Short-course Radiotherapy; Drug: Consolidation chemotherapy; Procedure: TME |
| Group es-SCRT | Experimental | Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) Receives: Radiation: Local dose increase of Short-course Radiotherapy; Drug: Consolidation chemotherapy; Procedure: TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy
Measured: 1 year
Secondary outcomes (3)
3y OS
3-year overall survival
Measured: 3 years
3yDMFS
3-year distant metastatic free survival
Measured: 3 years
3yLRRFS
3-year locoregional recurrence-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Jin, M.D.
- Responsible party
- Sponsor-investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
- Investigators
- Yuan Tang, M.D., Study director, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664504
- Sponsor's protocol ID
- 3332019055
- Status last verified
- Jun 2021
- First submitted
- 6 Dec 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
- ClinicalTrials.gov ID
- NCT04664504
- Acronym / sponsor ID
- 3332019055
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, Neoadjuvant Chemoradiotherapy, Recurrence Risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jing Jin, M.D.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Dec 2020 (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.
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Detailed description
For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group CRT | Active comparator | Combination Product: Concurrent Chemoradiotherapy Radiotherapy, Drug: Adjuvant chemotherapy, Procedure: TMEconcurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group) |
| Group SCRT | Experimental | Radiation: Short-course Radiotherapy, Drug: Consolidation chemotherapy, Procedure: TMEShort-course radiotherapy→ consolidation chemotherapy → TME (experimental group) |
| Group es-SCRT | Experimental | Radiation: Local dose increase of Short-course Radiotherapy, Drug: Consolidation chemotherapy, Procedure: TMELocal dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rectal adenocarcinoma confirmed by histopathology
- MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
- The age is 18-75 years old, no gender limit
- 3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
Key exclusion criteria (6 listed)
- History of other malignant tumors;
- They were allergic to 5-FU, platinum, etc;
- The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
- After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
- History of gastrointestinal fistula, perforation or severe ulcer;
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 Chemoradiotherapy RadiotherapyAlso: CRT50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d. | Combination product | Group CRT |
| Short-course RadiotherapyAlso: SCRT25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. | Radiation | Group SCRT |
| Local dose increase of Short-course RadiotherapyAlso: es-SCRT25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. | Radiation | Group es-SCRT |
| Consolidation chemotherapyAlso: XEOLX*4 coursesIntravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course. | Drug | Group SCRT, Group es-SCRT |
| Adjuvant chemotherapyAlso: XEOLX*6 courses2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses*3 weeks per course | Drug | Group CRT |
| TMETotal mesorectal excision | Procedure or surgery | Group CRT, Group SCRT, Group es-SCRT |
Primary outcome
R0 resection rate
Time frame: 1 year
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy
3 secondary outcomes
3y OS
Time frame: 3 years
3yDMFS
Time frame: 3 years
3yLRRFS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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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.
Yuan Tang, M.D. study director
Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concurrent Chemoradiotherapy Radiotherapy, Short-course Radiotherapy and Local dose increase of Short-course Radiotherapy in people with Rectal Cancer, run by Jing Jin, M.D. at 1 site in China.
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 4 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 8 Jun 2021. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yuan Tang, M.D. (+8615011304945, tangyuan82@162.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 1 year). 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 8 Jun 2021.