Rectum CancerPhase 2NCT02423226
Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
A Phase 2 study testing Computed tomography guided radioactive seeds implant and Systemic chemotherapy (FOLFIRI) in people with Rectum Cancer, run by The First People's Hospital of Changzhou.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- Computed tomography guided radioactive seeds implant and Systemic chemotherapy (FOLFIRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy
- Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
- Age range 18-70 years old
- ECOG performance status 0-1
- Life expectancy of more than 3 months
- Adequate organ function
Who cannot join
- Previous serious cardiac disease
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Chronic inflammatory bowel disease or intestinal obstruction
- Serious uncontrolled diseases and intercurrent infection
About this study
Official title: Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.
Read the detailed description
The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.
- Conditions
- Rectum Cancer
- Being tested
- Computed tomography guided radioactive seeds implant, Systemic chemotherapy (FOLFIRI)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography guided radioactive seeds implantProcedure or surgery
Also called Brachytherapy
Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.
Systemic chemotherapy (FOLFIRI)Drug
Also called FOLFIRI
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CT alone | Active comparator | Treated with systemic chemotherapy alone (FOLFIRI). Receives: Drug: Systemic chemotherapy (FOLFIRI) |
| CT+BT | Experimental | Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant. Receives: Procedure: Computed tomography guided radioactive seeds implant; Drug: Systemic chemotherapy (FOLFIRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival which is calculated from the start of treatment to disease progression or death
Measured: One year
Secondary outcomes (1)
Treatment related adverse events
Including chemotherapy related side-effect and brachytherapy related adverse events.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startOct 2008
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangrong Shi, The First People's Hospital of Changzhou
- Investigators
- Changping Wu, M.D., Study director, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423226
- Sponsor's protocol ID
- CZ-I125-001
- Status last verified
- Apr 2015
- First submitted
- 16 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
- ClinicalTrials.gov ID
- NCT02423226
- Acronym / sponsor ID
- CZ-I125-001
- Conditions
- Rectum Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Apr 2015 (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.
The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.
Detailed description
The primary aim of this study is to determined the safety and efficacy of CT guided 125I seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and survival data were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT alone | Active comparator | Drug: Systemic chemotherapy (FOLFIRI)Treated with systemic chemotherapy alone (FOLFIRI). |
| CT+BT | Experimental | Procedure: Computed tomography guided radioactive seeds implant, Drug: Systemic chemotherapy (FOLFIRI)Treated with systemic chemotherapy (FOLFIRI) plus computed tomography guided radioactive seeds implant. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Limited locoregional recurrence including solitary recurrence at primary tumor bed, solitary intraabdominal peritoneal recurrence, and single regional lymph node recurrence (no more than 3 lymph nodes) based on diagnosis by CT, and confirmed by percutaneous puncture biopsy
- Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
- Age range 18-70 years old
- ECOG performance status 0-1
- Life expectancy of more than 3 months
Key exclusion criteria (5 listed)
- Previous serious cardiac disease
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Chronic inflammatory bowel disease or intestinal obstruction
- Serious uncontrolled diseases and intercurrent infection
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 |
|---|---|---|
| Computed tomography guided radioactive seeds implantAlso: BrachytherapyComputed tomography guided radioactive seeds implant were performed one week before chemotherapy. | Procedure or surgery | CT+BT |
| Systemic chemotherapy (FOLFIRI)Also: FOLFIRIirinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks | Drug | CT alone, CT+BT |
Primary outcome
Progression free survival
Time frame: One year
Progression free survival which is calculated from the start of treatment to disease progression or death
1 secondary outcome
Treatment related adverse events
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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.
Changping Wu, M.D. study director
The First People's Hospital of Changzhou
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computed tomography guided radioactive seeds implant and Systemic chemotherapy (FOLFIRI) in people with Rectum Cancer, run by The First People's Hospital of Changzhou.
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 5 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: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (time frame: One 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 22 Apr 2015.