Locally Advanced Malignant NeoplasmPhase 2NCT01871363
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
A Phase 2 study testing chemoradiation in people with Locally Advanced Malignant Neoplasm, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Malignant Neoplasm
- What is being tested?
- chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4 or any node positive disease (clinical stage according the TNM classification system)
- No evidence of metastatic disease.
- Age 18 - 65 years
- Kps 80-100
- No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
- Normal hematological, hepatic and renal function, Ability to swallow tablets
- Signed informed consent
- Patients must be willing and able to comply with the protocol for duration of the study
Who cannot join
- Malignancy of the rectum other than adenocarcinoma
- Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
- Evidence of active peptic ulcer or upper GI bleeding
- Evidence of bleeding diathesis or coagulopathy
- Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin
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- Known hypersensitivity to biological drugs
- Treatment with any investigational drug within 30 days before beginning treatment with the study drug
- Pregnant or lactating patient
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, CAMS
Beijing, 100021
Jing Jin, proffessor, 8610-87788280, jingjin1025@163.com
Hua Ren, Attening, 8610-87788122, renhua2009@hotmail.com
About this study
Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
- Conditions
- Locally Advanced Malignant Neoplasm
- Being tested
- chemoradiation
- Keywords
- Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiationRadiation
Also called Preoperative Radiotherapy With Capecitabine and Bevacizumab
- radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel.
- capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends),
- bevacizumab: at dose 5 mg/kg on days -1, 15, 31.
- Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.
| Study group | Role | What they receive |
|---|---|---|
| preoperative chemoradiation | Experimental | * radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel.
* capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends),
* bevacizumab: at dose 5 mg/kg on days -1, 15,31.
* Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation. Receives: Radiation: chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission rate (pCR)
A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR)
Measured: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary outcomes (1)
Acute and late toxicity
Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.
late toxicites will be assessed every 6 months from the third year after surgery.
Measured: Toxicity/safety:during preoperative treatment, early and late postoperative follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Malignant 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Ren, Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, proffessor, Study chair, Dept of Radiation oncology, Cancer hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871363
- Sponsor's protocol ID
- CH-GI-027
- Status last verified
- Jun 2013
- First submitted
- 19 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT01871363
- Acronym / sponsor ID
- CH-GI-027
- Conditions
- Locally Advanced Malignant Neoplasm
- Keywords
- Preoperative Chemoradiotherapy, Bevacizumab, Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (estimated)
- First posted
- 6 Jun 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.
Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative chemoradiation | Experimental | Radiation: chemoradiation* radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel. * capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends), * bevacizumab: at dose 5 mg/kg on days -1, 15,31. * Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4 or any node positive disease (clinical stage according the TNM classification system)
- No evidence of metastatic disease.
- Age 18 - 65 years
- Kps 80-100
- No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
Key exclusion criteria (9 listed)
- Malignancy of the rectum other than adenocarcinoma
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 |
|---|---|---|
| chemoradiationAlso: Preoperative Radiotherapy With Capecitabine and Bevacizumab* radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel. * capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends), * bevacizumab: at dose 5 mg/kg on days -1, 15, 31. * Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation. | Radiation | preoperative chemoradiation |
Primary outcome
Pathological complete remission rate (pCR)
Time frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
A TME surgery will be done 6-8 weeks after concurrent chemoradiation, pathological examination of surgical speciments will be show Pathological complete remission rate (pCR)
1 secondary outcome
Acute and late toxicity
Time frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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, proffessor study chair
Dept of Radiation oncology, Cancer hospital, CAMS
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 chemoradiation in people with Locally Advanced Malignant Neoplasm, 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 9 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 6 Jun 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 Jing Jin, professor (87788280, jingjin1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission rate (pCR) (time frame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)). 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 6 Jun 2013.