Advanced Rectal CancerPhase 3NCT02031939
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
A Phase 3 study testing Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin) and standard chemoradiotherapy in people with Advanced Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Rectal Cancer
- What is being tested?
- Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin) and standard chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological confirmed rectal cancer
- Clinical stage T3-4 or T any N1
- No metastasis
- Distance of tumor is no more than 10cm from anal verge
- No previous radiotherapy
- Age ranged from 18 to 70
- Eastern Cooperative Oncology Group score system 0-1
Who cannot join
- Clinical stage T1-2 N0
- Distance metastasis
- Multiple primary tumor
- Cachexy
Trial locations and contacts
1 site in 1 country.
About this study
Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.
- Conditions
- Advanced Rectal Cancer
- Being tested
- Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin), standard chemoradiotherapy
- Keywords
- Rectal cancer, neoadjuvant chemoradiotherapy, optimization
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)Drug
All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery.
standard chemoradiotherapyRadiation
All rectal patients in this group will receive standard radiotherapy and surgical resection.
| Study group | Role | What they receive |
|---|---|---|
| Standard chemoradiotherapy | Active comparator | Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy ) Receives: Radiation: standard chemoradiotherapy |
| induction and gap chemotherapy | Experimental | induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2) Receives: Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Secondary outcomes (3)
disease free survival
Measured: 3 years
Disease free survival
Measured: 5 years
Respond rate
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2020
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Hai Lu, Sun Yat-sen University
- Investigators
- Zhen-Hai Lu, Prof., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031939
- Sponsor's protocol ID
- 2013013
- Other IDs
- SYSU5010Fund
- Status last verified
- Aug 2023
- First submitted
- 30 Dec 2013
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02031939
- Acronym / sponsor ID
- 2013013
- Conditions
- Advanced Rectal Cancer
- Keywords
- Rectal cancer, neoadjuvant chemoradiotherapy, optimization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jan 2014 (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.
Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard chemoradiotherapy | Active comparator | Radiation: standard chemoradiotherapyStandard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy ) |
| induction and gap chemotherapy | Experimental | Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathological confirmed rectal cancer
- Clinical stage T3-4 or T any N1
- No metastasis
- Distance of tumor is no more than 10cm from anal verge
- No previous radiotherapy
Key exclusion criteria (4 listed)
- Clinical stage T1-2 N0
- Distance metastasis
- Multiple primary tumor
- Cachexy
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 |
|---|---|---|
| Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)All rectal cancer patients in this group will receive induction, gap chemotherapy (capecitabine combined with oxaliplatin) alone with chemoradiotherapy (capecitabine combine with oxaliplatin) before surgery. | Drug | induction and gap chemotherapy |
| standard chemoradiotherapyAll rectal patients in this group will receive standard radiotherapy and surgical resection. | Radiation | Standard chemoradiotherapy |
Primary outcome
overall survival
Time frame: 5 years
3 secondary outcomes
disease free survival
Time frame: 3 years
Disease free survival
Time frame: 5 years
Respond rate
Time frame: One week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
Zhen-Hai Lu, Prof. principal investigator
Sun Yat-sen University
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 Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin) and standard chemoradiotherapy in people with Advanced Rectal Cancer, run by Sun Yat-sen University 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 7 inclusion and 4 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 25 Aug 2023. 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 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?
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?
overall survival (time frame: 5 years). 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 25 Aug 2023.