Rectal CancerPhase 2NCT05807984
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
A Phase 2 study testing Carbon ion radiation therapy DT: 74Gy/20 fractions in people with Rectal Cancer and Recurrent, run by Xin Cai at 1 site in China.
Trial summary
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Recurrent
- What is being tested?
- Carbon ion radiation therapy DT: 74Gy/20 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
- 2) received a radical operation for their primary tumor and regional lymph nodes,
- 3) received chemo-radiation or radiation in pelvic before CIRT,
- 4) received re-irradiation by CIRT after their pelvic radiotherapy.
Who cannot join
- 1) received more than once prior radiotherapy in the same treatment field,
- 2) time to the last radiotherapy was <1 year,
- 3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Proton and Heavy ion center
Shanghai, Pudong, 201321
Xin Cai, Doctor, +86 13901601072, xin.cai@sphic.org.cn
About this study
Official title: A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)
- Conditions
- Rectal Cancer, Recurrent
- Being tested
- Carbon ion radiation therapy DT: 74Gy/20 fractions
- Medical subject headings
- Rectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon ion radiation therapy DT: 74Gy/20 fractionsRadiation
patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation
| Study group | Role | What they receive |
|---|---|---|
| carbon ion therapy for unresectable local recurrent rectal cancer | Experimental | Not described Receives: Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control
local control rate of the lesion treated by CIRT
Measured: Local control at 3 years after CIRT
Secondary outcomes (2)
overall survival
survival rate after CIRT
Measured: 3 years after CIRT or patient died, measured erery 3 months after CIRT
progression free survival
progression free survival rate after CIRT
Measured: 3 years after CIRT or patient died, measured erery 3 months after CIRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- carbon ion therapy
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Cai, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807984
- Sponsor's protocol ID
- SPHIC-TR-CRC2021-01
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT05807984
- Acronym / sponsor ID
- SPHIC-TR-CRC2021-01
- Conditions
- Rectal Cancer, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Xin CaiUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2023 (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.
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- carbon ion therapy
| Arm | Type | Receives |
|---|---|---|
| carbon ion therapy for unresectable local recurrent rectal cancer | Experimental | Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
- 2) received a radical operation for their primary tumor and regional lymph nodes,
- 3) received chemo-radiation or radiation in pelvic before CIRT,
- 4) received re-irradiation by CIRT after their pelvic radiotherapy.
Key exclusion criteria (3 listed)
- 1) received more than once prior radiotherapy in the same treatment field,
- 2) time to the last radiotherapy was <1 year,
- 3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).
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 |
|---|---|---|
| Carbon ion radiation therapy DT: 74Gy/20 fractionspatients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation | Radiation | carbon ion therapy for unresectable local recurrent rectal cancer |
Primary outcome
local control
Time frame: Local control at 3 years after CIRT
local control rate of the lesion treated by CIRT
2 secondary outcomes
overall survival
Time frame: 3 years after CIRT or patient died, measured erery 3 months after CIRT
progression free survival
Time frame: 3 years after CIRT or patient died, measured erery 3 months after CIRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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 Carbon ion radiation therapy DT: 74Gy/20 fractions in people with Rectal Cancer and Recurrent, run by Xin Cai 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 Apr 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Cai, Doctor (+86 13901601072, xin.cai@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control (time frame: Local control at 3 years after CIRT). 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 11 Apr 2023.