Rectal NeoplasmsPhase 2NCT01930942
Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma
A Phase 2 study testing preoperative concurrent chemoradiation in people with Rectal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- preoperative concurrent chemoradiation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Dec 2017
- 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 adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- Distance from the lower bound of tumor to the anal verge is less than 12 cm.
- KPS score not less than 70
- Can be tolerated chemotherapy and radiotherapy.
- No history of radiation therapy to the pelvis.
- Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
- 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
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100021
Jing Jin, MD, +8613601365130, jingjin1025@163.com
About this study
The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.
Read the detailed description
For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.
- Conditions
- Rectal Neoplasms
- Being tested
- preoperative concurrent chemoradiation
- Keywords
- rectal carcinoma, preoperative concurrent chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative concurrent chemoradiationRadiation
Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
| Study group | Role | What they receive |
|---|---|---|
| preoperative concurrent chemoradiation | Experimental | Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation. Receives: Radiation: preoperative concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression in different response groups
Measured: 6 months after radical surgery
Secondary outcomes (1)
overall survival, disease free survival and local-regional free survival
Measured: 3 years after pre-operative chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJan 2006
- Primary completionDec 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 NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930942
- Sponsor's protocol ID
- D0905001040531
- Status last verified
- Jan 2016
- First submitted
- 14 Aug 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT01930942
- Acronym / sponsor ID
- D0905001040531
- Conditions
- Rectal Neoplasms
- Keywords
- rectal carcinoma, preoperative concurrent chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Aug 2013 (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 aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.
Detailed description
For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative concurrent chemoradiation | Experimental | Radiation: preoperative concurrent chemoradiationRadiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0).
- Distance from the lower bound of tumor to the anal verge is less than 12 cm.
- KPS score not less than 70
- Can be tolerated chemotherapy and radiotherapy.
- No history of radiation therapy to the pelvis.
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 |
|---|---|---|
| preoperative concurrent chemoradiationRadiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation. | Radiation | preoperative concurrent chemoradiation |
Primary outcome
gene expression in different response groups
Time frame: 6 months after radical surgery
1 secondary outcome
overall survival, disease free survival and local-regional free survival
Time frame: 3 years after pre-operative chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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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, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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 preoperative concurrent chemoradiation in people with Rectal Neoplasms, 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 7 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 5 Jan 2016. 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, MD (+86-13601365130, jingjin1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression in different response groups (time frame: 6 months after radical surgery). 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 5 Jan 2016.