Rectal CancerPhase 2NCT04543695
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
A Phase 2 study testing Concurrent Chemoradiotherapy, XELOX and mFOLFOX in people with Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer 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, XELOX and mFOLFOX
- 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
- 255 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to 1 Jun 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
- 18-75 years old, regardless of gender
- Histologically confirmed rectal adenocarcinoma;
- Up to 12 cm above the anal verge on the basis of rigid rectoscopy.
- MRI of the rectum is acceptable;
- Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement.
- ECOG score 0-1 or KPS score ≥80.
Who cannot join
- History of malignant tumor in other parts;
- Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;
- During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
- History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;
- History of digestive tract fistula, perforation or severe ulcer;
- Active infection is present; Clinically obvious heart disease; New York heart association (NYHA) of Ⅱ level or 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
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100021
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
Read the detailed description
Recommended treatment of patients with locally advanced rectal cancer (LARC) includes preoperative chemoradiation (CRT), total mesorectal excision (TME) and postoperative adjuvant chemotherapy (ACT). However, treatments fail to show an improved therapeutic effect on high-risk patients now. Total neoadjuvant therapy (TNT) is a new try for rectal cancer treatment,and this trial aims to identify and select the more promising TNT sequence.
This trail is a multicenter, randomized, phase II trial . Eligible patients age from 18 to 75 years with histologically confirmed rectal adenocarcinoma. MRI is mandatory, and patients of stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement. Patients are randomly assigned to 3 groups, group 1: concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group);or group 2: concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group);Or group 3: induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).The primary end point is the rate of tumor down-staging, which is defined as stage yp0-II after surgery,and watch-and-wait strategy after complete clinical response (cCR) was allowed. Secondary end points include acute toxicity, compliance with TNT, surgical complications, 3-year overall survival (3yOS),3-year disease free survival (3yDFS),3-year distant metastatic free survival(3yDMFS),3-year locoregional recurrence-free survival(3yLRRFS) and quality of life.
- Conditions
- Rectal Cancer
- Being tested
- Concurrent Chemoradiotherapy, XELOX, mFOLFOX, TME
- Keywords
- Rectal Cancer, Radiotherapy, High Risk, Total Neoadjuvant Therapy
- 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 ChemoradiotherapyCombination product
Radiotherapy:
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Concurrent chemotherapy:
Capecitabine 1650 mg/m2/d
XELOXDrug
Also called CAOPX
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 6 cycles.
6 courses，3 weeks per course
mFOLFOXDrug
Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 9 cycles.
TMEProcedure or surgery
Total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| adjuvant chemotherapy group | Active comparator | concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group) Receives: Combination Product: Concurrent Chemoradiotherapy; Drug: XELOX; Drug: mFOLFOX; Procedure: TME |
| consolidation chemotherapy group (CNCT group) | Experimental | concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group) Receives: Combination Product: Concurrent Chemoradiotherapy; Drug: XELOX; Drug: mFOLFOX; Procedure: TME |
| induction chemotherapy group (INCT group) | Experimental | induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group). Receives: Combination Product: Concurrent Chemoradiotherapy; Drug: XELOX; Drug: mFOLFOX; Procedure: TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of tumor down-staging
Tumor down-staging is considered as Stage yp0-II after surgery, and watch-and-wait strategy after complete clinical response (cCR) was allowed.
Measured: 6-8 months
Secondary outcomes (10)
Rate of compliance with TNT
Rate of compliance with TNT
Measured: 6-8 months
3y OS
3-year overall survival (3yOS)
Measured: 3years
3y DFS
3-year disease free survival (3yDFS)
Measured: 3years
3y DMFS
3-year distant metastatic free survival(3yDMFS)
Measured: 3 years
3y LRRFS
3-year locoregional recurrence-free survival(3yLRRFS)
Measured: 3 years
EORTC QLQ-C30
EORTC QLQ-C30 to assess the quality of life
Measured: 3 years
EORTC QLQ-CR29
EORTC QLQ-CR29 to assess the quality of life
Measured: 3 years
Wexner continence grading scale
Wexner continence grading scale
Measured: 3 years
CTCAE 4.0
Severe acute adverse reaction rate（≥III degree）
Measured: 6-8months
Incidence of surgical complications
Incidence of surgical complications
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start15 Aug 2020
- Primary completion12 Jul 2022
- Study completion1 Jun 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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Peking Union Medical College Hospital, Jilin Provincial Tumor Hospital, Cancer Hospital of Guizhou Province, Xijing Hospital
- Responsible party
- Principal investigator, JIN JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, M.D., Study director, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543695
- Sponsor's protocol ID
- NCC201809007
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04543695
- Acronym / sponsor ID
- NCC201809007
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, Radiotherapy, High Risk, Total Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Peking Union Medical College Hospital, Jilin Provincial Tumor Hospital, Cancer Hospital of Guizhou Province, Xijing Hospital
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Sep 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 Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
Detailed description
Recommended treatment of patients with locally advanced rectal cancer (LARC) includes preoperative chemoradiation (CRT), total mesorectal excision (TME) and postoperative adjuvant chemotherapy (ACT). However, treatments fail to show an improved therapeutic effect on high-risk patients now. Total neoadjuvant therapy (TNT) is a new try for rectal cancer treatment,and this trial aims to identify and select the more promising TNT sequence.
This trail is a multicenter, randomized, phase II trial . Eligible patients age from 18 to 75 years with histologically confirmed rectal adenocarcinoma. MRI is mandatory, and patients of stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement. Patients are randomly assigned to 3 groups, group 1: concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group);or group 2: concurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group);Or group 3: induction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group).The primary end point is the rate of tumor down-staging, which is defined as stage yp0-II after surgery,and watch-and-wait strategy after complete clinical response (cCR) was allowed. Secondary end points include acute toxicity, compliance with TNT, surgical complications, 3-year overall survival (3yOS),3-year disease free survival (3yDFS),3-year distant metastatic free survival(3yDMFS),3-year locoregional recurrence-free survival(3yLRRFS) and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adjuvant chemotherapy group | Active comparator | Combination Product: Concurrent Chemoradiotherapy, Drug: XELOX, Drug: mFOLFOX, Procedure: TMEconcurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group) |
| consolidation chemotherapy group (CNCT group) | Experimental | Combination Product: Concurrent Chemoradiotherapy, Drug: XELOX, Drug: mFOLFOX, Procedure: TMEconcurrent chemoradiotherapy → consolidation chemotherapy → TME (CNCT group) |
| induction chemotherapy group (INCT group) | Experimental | Combination Product: Concurrent Chemoradiotherapy, Drug: XELOX, Drug: mFOLFOX, Procedure: TMEinduction chemotherapy → concurrent chemoradiotherapy →TME ( INCT group). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years old, regardless of gender
- Histologically confirmed rectal adenocarcinoma;
- Up to 12 cm above the anal verge on the basis of rigid rectoscopy.
- MRI of the rectum is acceptable;
- Patients in stage II or III rectal cancer are eligible if any of the following criteria are fulfilled: Categories T4,Categories N2, MRF involvement, EMVI positive, and lateral lymph node involvement.
Key exclusion criteria (6 listed)
- History of malignant tumor in other parts;
- Cannot complete MRI; Allergic to 5-fu drugs; Allergic to platinum drugs;
- During thrombolytic and anticoagulant therapy, the patient has bleeding diathesis or coagulation dysfunction; Or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
- History of kidney, urine test found proteinuria or clinical renal function was significantly abnormal;
- History of digestive tract 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 ChemoradiotherapyRadiotherapy: 50Gy 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 | adjuvant chemotherapy group, consolidation chemotherapy group (CNCT group), induction chemotherapy group (INCT group) |
| XELOXAlso: CAOPXIntravenous 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 6 cycles. 6 courses，3 weeks per course | Drug | adjuvant chemotherapy group, consolidation chemotherapy group (CNCT group), induction chemotherapy group (INCT group) |
| mFOLFOXAdministration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 9 cycles. | Drug | adjuvant chemotherapy group, consolidation chemotherapy group (CNCT group), induction chemotherapy group (INCT group) |
| TMETotal mesorectal excision | Procedure or surgery | adjuvant chemotherapy group, consolidation chemotherapy group (CNCT group), induction chemotherapy group (INCT group) |
Primary outcome
The rate of tumor down-staging
Time frame: 6-8 months
Tumor down-staging is considered as Stage yp0-II after surgery, and watch-and-wait strategy after complete clinical response (cCR) was allowed.
10 secondary outcomes
Rate of compliance with TNT
Time frame: 6-8 months
3y OS
Time frame: 3years
3y DFS
Time frame: 3years
3y DMFS
Time frame: 3 years
3y LRRFS
Time frame: 3 years
EORTC QLQ-C30
Time frame: 3 years
EORTC QLQ-CR29
Time frame: 3 years
Wexner continence grading scale
Time frame: 3 years
CTCAE 4.0
Time frame: 6-8months
Incidence of surgical complications
Time frame: 6-8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Jing Jin, 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, XELOX and mFOLFOX in people with Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 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 26 Mar 2024. 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?
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?
The rate of tumor down-staging (time frame: 6-8 months). 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 26 Mar 2024.