Rectal NeoplasmNCT02630056
Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer
An observational study of Rectal Neoplasm, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasm
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both gender is OK and there is no limitation for age.
Who may be able to join
- rectal cancer
- receive neoadjuvant chemoradiotherapy
Who cannot join
- hematological system disorders
About this study
Official title: Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer Treated With Neoadjuvant Chemoradiotherapy
The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.
Read the detailed description
The investigators' ongoing retrospective study investigated the clinical and dosimetric parameter (dosimetry of pelvic bone marrow) which relate with acute hematologic toxicity in patient with rectal cancer treated with neoadjuvant chemoradiotherapy. In order to validate the dosimetric limitation of pelvic bone marrow in decreasing the intensity of HT, the investigators want to conduct a study to observe the acute HT without assigning any specific interventions to the subjects of the study, who will receive the standard treatment according to the multidisciplinary team's (MDT) decision and patient choice. Therefore, this study's type is observational.
- Conditions
- Rectal Neoplasm
- Keywords
- radiotherapy hematologic toxicity pelvic bone marrow
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the grade of acute hematologic toxicity
Hematologic Adverse Events That Are Related to Pelvic Bone Marrow Irradiation
Measured: 5-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630056
- Sponsor's protocol ID
- SASYSU
- Status last verified
- Nov 2015
- First submitted
- 27 Nov 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer Treated With Neoadjuvant Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02630056
- Acronym / sponsor ID
- SASYSU
- Conditions
- Rectal Neoplasm
- Keywords
- radiotherapy hematologic toxicity pelvic bone marrow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Dec 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 validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.
Detailed description
The investigators' ongoing retrospective study investigated the clinical and dosimetric parameter (dosimetry of pelvic bone marrow) which relate with acute hematologic toxicity in patient with rectal cancer treated with neoadjuvant chemoradiotherapy. In order to validate the dosimetric limitation of pelvic bone marrow in decreasing the intensity of HT, the investigators want to conduct a study to observe the acute HT without assigning any specific interventions to the subjects of the study, who will receive the standard treatment according to the multidisciplinary team's (MDT) decision and patient choice. Therefore, this study's type is observational.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both gender is OK and there is no limitation for age.
Key inclusion criteria (2 listed)
- rectal cancer
- receive neoadjuvant chemoradiotherapy
Key exclusion criteria (1 listed)
- hematological system disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the grade of acute hematologic toxicity
Time frame: 5-6 weeks
Hematologic Adverse Events That Are Related to Pelvic Bone Marrow Irradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasm, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 1 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 15 Dec 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.
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 grade of acute hematologic toxicity (time frame: 5-6 weeks). 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 15 Dec 2015.