Rectal CancerNCT05688033
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
A study testing dosimetric limitation of pelvic bone and peritoneal space during radiotherapy in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2023
- Phase
- Interventional
- 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
- Patients with rectal adenocarcinoma
- Clinical staged T3/4 or any node-positive disease
- Age of 18-75 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve, renal and hepatic functions
- Without previous antitumoural chemotherapy
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- No evidence of metastatic disease
- Written informed consent before randomization
- UGT1A1's genotype of 6/6 or 6/7
Who cannot join
- Clinical staged I or IV
- Age of <18 or >75 years
- Karnofsky Performance Status < 80
- Previous pelvis radiotherapy
- Previous antitumoural chemotherapy
- Clinically significant internal disease
- Refuse to write informed consent before randomization
- UGT1A1's genotype of 7/7
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.
- Conditions
- Rectal Cancer
- Being tested
- dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosimetric limitation of pelvic bone and peritoneal space during radiotherapyRadiation
dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | peritoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation Receives: Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy |
| control arm | No intervention | normal dosimetric limitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
Measured: up to 3 years
Secondary outcomes (1)
Number of Participants in Who Experienced Tumor Down-staging
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jan 2021
- Primary completion30 Aug 2022
- Study completion30 Dec 2023 (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 Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688033
- Sponsor's protocol ID
- IMRTGI0001
- Status last verified
- Jan 2023
- First submitted
- 29 Oct 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan
- ClinicalTrials.gov ID
- NCT05688033
- Acronym / sponsor ID
- IMRTGI0001
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 18 Jan 2023 (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.
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapyperitoneal space V15<850cc，pelvic bone V10<80% and normal dosimetric limitation |
| control arm | No intervention | –normal dosimetric limitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with rectal adenocarcinoma
- Clinical staged T3/4 or any node-positive disease
- Age of 18-75 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve, renal and hepatic functions
Key exclusion criteria (8 listed)
- Clinical staged I or IV
- Age of <18 or >75 years
- Karnofsky Performance Status < 80
- Previous pelvis radiotherapy
- Previous antitumoural chemotherapy
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 |
|---|---|---|
| dosimetric limitation of pelvic bone and peritoneal space during radiotherapydosimetric limitation of pelvic bone and peritoneal space during radiotherapy | Radiation | experimental arm |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: up to 3 years
1 secondary outcome
Number of Participants in Who Experienced Tumor Down-staging
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- 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.
Zhen Zhang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dosimetric limitation of pelvic bone and peritoneal space during radiotherapy in people with Rectal Cancer, run by Fudan 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 9 inclusion and 8 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 18 Jan 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.
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?
Number of Participants Experiencing Adverse Events (time frame: up to 3 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 18 Jan 2023.