Anal CancerPhase 2NCT03381352
Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
A Phase 2 study testing Chemo-radiotherapy with IMRT technique, Capecitabine and Mitomycin C in people with Anal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Chemo-radiotherapy with IMRT technique, Capecitabine and Mitomycin C
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2015to 31 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT/MRI diagnosed stage cT1-4N0-3;
- Histologically confirmed anal squamous carcinoma;
- KPS >= 70
- Adequate organ function;
- No previous radiotherapy or chemotherapy;
- No surgery.
Who cannot join
- Previous malignant cancer history;
- Allegic to 5-fu or MMC
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese academy of medical sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD, 0086-13810381399, lee_ak@163.com
About this study
Official title: Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.
- Conditions
- Anal Cancer
- Being tested
- Chemo-radiotherapy with IMRT technique, Capecitabine, Mitomycin C
- Keywords
- Radiotherapy, Anal cancer, IMRT
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemo-radiotherapy with IMRT techniqueRadiation
IMRT radiation technique; 50.4-54Gy/25F
CapecitabineDrug
Capecitabine 825mg/m2 PO BID
Mitomycin CDrug
Mitomycin C 10mg/m2 D1,29 iv
| Study group | Role | What they receive |
|---|---|---|
| Chemo-radiotherapy with IMRT technique | Experimental | Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy Receives: Radiation: Chemo-radiotherapy with IMRT technique; Drug: Capecitabine; Drug: Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
To evaluate response rate of IMRT with chemotherapy
Measured: 8 weeks after IMRT
Secondary outcomes (1)
Adverse events
To assess the adverse events of IMRT with chemotherapy
Measured: from start of IMRT to 8 weeks after IMRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start2 Dec 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Ning, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381352
- Sponsor's protocol ID
- Y-MX2015-014
- Status last verified
- Jan 2018
- First submitted
- 13 Dec 2017
- Last updated
- 30 Jan 2018
- 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 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
- ClinicalTrials.gov ID
- NCT03381352
- Acronym / sponsor ID
- Y-MX2015-014
- Conditions
- Anal Cancer
- Keywords
- Radiotherapy, Anal cancer, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Dec 2017 (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.
The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo-radiotherapy with IMRT technique | Experimental | Radiation: Chemo-radiotherapy with IMRT technique, Drug: Capecitabine, Drug: Mitomycin CRadiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CT/MRI diagnosed stage cT1-4N0-3;
- Histologically confirmed anal squamous carcinoma;
- KPS >= 70
- Adequate organ function;
- No previous radiotherapy or chemotherapy;
Key exclusion criteria (2 listed)
- Previous malignant cancer history;
- Allegic to 5-fu or MMC
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 |
|---|---|---|
| Chemo-radiotherapy with IMRT techniqueIMRT radiation technique; 50.4-54Gy/25F | Radiation | Chemo-radiotherapy with IMRT technique |
| CapecitabineCapecitabine 825mg/m2 PO BID | Drug | Chemo-radiotherapy with IMRT technique |
| Mitomycin CMitomycin C 10mg/m2 D1,29 iv | Drug | Chemo-radiotherapy with IMRT technique |
Primary outcome
Response rate
Time frame: 8 weeks after IMRT
To evaluate response rate of IMRT with chemotherapy
1 secondary outcome
Adverse events
Time frame: from start of IMRT to 8 weeks after IMRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Anal Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
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 Chemo-radiotherapy with IMRT technique, Capecitabine and Mitomycin C in people with Anal 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 6 inclusion and 2 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 30 Jan 2018. 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 (0086-13810381399, lee_ak@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 8 weeks after IMRT). 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 30 Jan 2018.