Rectal CancerPhase 2NCT01586117
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
A Phase 2 study testing Amifostine in people with Rectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy. 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?
- Amifostine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 2014
- 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
- pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- tumor distance from anus less than 12 cm.
- KPS score not less than 70
- can be tolerated chemotherapy and radiotherapy.
- pelvic who had no history of radiation therapy.
- Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
- blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90).
- a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.
Who cannot join
- other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
- pregnant or lactating patients.
- fertility but did not use contraceptive measures.
- existing active infection.
- merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
- concurrent treatment with other anticancer drugs.
- can not complete treatment or follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Radiation Oncology Depratment, Cancer Hospital, CAMS
Beijing, Beijing Municipality, 100021
Ning Li, MD, 86-13810381399, lee_ak@163.com
About this study
The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
Read the detailed description
To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
- Conditions
- Rectal Cancer
- Being tested
- Amifostine
- Keywords
- rectal cancer, amifostine, pre-operative chemo-radiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
intrarectal Amifostine administration 1500mg QD x 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amifostine | Experimental | intrarectal Amifostine assign to the Amifostine arm Receives: Drug: Amifostine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute radiation-induced toxicity: daily diarrhea frequency
Measured: about 3 months from chemo-raditherapy to operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, M.D, Principal investigator, Chinese Acedemy of Medical Scinences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586117
- Sponsor's protocol ID
- CH-GI-022
- Status last verified
- Aug 2013
- First submitted
- 22 Apr 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
- ClinicalTrials.gov ID
- NCT01586117
- Acronym / sponsor ID
- CH-GI-022
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, amifostine, pre-operative chemo-radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Apr 2012 (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 effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
Detailed description
To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amifostine | Experimental | Drug: Amifostineintrarectal Amifostine assign to the Amifostine arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- tumor distance from anus less than 12 cm.
- KPS score not less than 70
- can be tolerated chemotherapy and radiotherapy.
- pelvic who had no history of radiation therapy.
Key exclusion criteria (7 listed)
- other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
- pregnant or lactating patients.
- fertility but did not use contraceptive measures.
- existing active infection.
- merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
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 |
|---|---|---|
| Amifostineintrarectal Amifostine administration 1500mg QD x 5 weeks | Drug | Amifostine |
Primary outcome
Acute radiation-induced toxicity: daily diarrhea frequency
Time frame: about 3 months from chemo-raditherapy to operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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, M.D principal investigator
Chinese Acedemy of Medical Scinences
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 Amifostine 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 8 inclusion and 7 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 Aug 2013. 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 Ning Li, MD (86-13810381399, lee_ak@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute radiation-induced toxicity: daily diarrhea frequency (time frame: about 3 months from chemo-raditherapy to operation). 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 Aug 2013.