Rectal CancerPhase 2NCT02195141
Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
A Phase 2 study testing conventional fraction and SIB in people with Rectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. 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?
- conventional fraction and SIB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2015
- 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
- histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
- the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
Who cannot join
- metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status > 3
- patients not deemed fit for radiotherapy, capecitabine or surgery
- pregnant or lactating patients
- women with child bearing potential who lack effective contraception
- patients below 18 years old
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, CAMS
Beijing, 100021
Jing Jin, professor, 87788200, jingjin1025@163.com
Hua Ren, attending, 87788122, renhua2009@hotmail.com
About this study
Official title: Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
- Conditions
- Rectal Cancer
- Being tested
- conventional fraction, SIB
- Keywords
- Preoperative Chemoradiotherapy, Locally Advanced Rectal Cancer, boost, IMRT
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional fractionRadiation
capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
SIBRadiation
Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
| Study group | Role | What they receive |
|---|---|---|
| conventional fraction | Active comparator | Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily Receives: Radiation: conventional fraction |
| SIB | Experimental | Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily Receives: Radiation: SIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Pathological complete remission rate (pCR)
Measured: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary outcomes (1)
Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Measured: during preoperative treatment and after surgery for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Ren, Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, proffessor, Study chair, Dept of Radiation oncology, Cancer hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195141
- Sponsor's protocol ID
- NCC2014-ST02
- Status last verified
- Feb 2015
- First submitted
- 11 Jul 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
- ClinicalTrials.gov ID
- NCT02195141
- Acronym / sponsor ID
- NCC2014-ST02
- Conditions
- Rectal Cancer
- Keywords
- Preoperative Chemoradiotherapy, Locally Advanced Rectal Cancer, boost, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Jul 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.
Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional fraction | Active comparator | Radiation: conventional fractionRadiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily |
| SIB | Experimental | Radiation: SIBConcomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
- the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
Key exclusion criteria (6 listed)
- metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status > 3
- patients not deemed fit for radiotherapy, capecitabine or surgery
- pregnant or lactating patients
- women with child bearing potential who lack effective contraception
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 |
|---|---|---|
| conventional fractioncapecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f | Radiation | conventional fraction |
| SIBConcomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily | Radiation | SIB |
Primary outcome
• Pathological complete remission rate (pCR)
Time frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
1 secondary outcome
Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time frame: during preoperative treatment and after surgery for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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, proffessor study chair
Dept of Radiation oncology, Cancer hospital, CAMS
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 conventional fraction and SIB in people with Rectal Cancer, run by 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 2 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 4 Feb 2015. 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 Jing Jin, Professor (87788280, jingjin1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Pathological complete remission rate (pCR) (time frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)). 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 4 Feb 2015.