Safety and EfficacyUNLACCNCT06244537
Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
A study testing MR-linac in people with Safety and Efficacy, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
In this phase I single-arm clinical study, 20 patients with T4 unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety and Efficacy
- What is being tested?
- MR-linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- Patients can remain in a stationary position on the treatment bed for 1-1.5 hours
- ECOG score 0-1
- Pathological diagnosis of colon adenocarcinoma, clinical stage cT4N0-2M0
- Organ function is normal, and the following conditions are required: white blood cell count ≥3.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90g/L. Total bilirubin level ≤1.5× upper limit of normal (ULN); AST and ALT levels ≤2.5 × ULN; endogenous creatinine clearance rate: 56-122ml/min; serum creatinine <1.0× ULN; serum albumin ≥30g/L.
- Able to adhere to the study protocol during the research period
- Signed written informed consent
Who cannot join
- Patients with dMMR or MSI-H
- Presence of other types of tumors in addition to colon adenocarcinoma
- Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons
- Distant metastasis (M1)
- Pregnant or lactating women
- Previous anti-tumor treatment
Show all 12Show fewer
- Concurrent use of prohibited drugs for treatment
- Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome.
- Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina pectoris, congestive heart failure (≥New York Heart Association class II) or severe arrhythmia requiring medication treatment
- Individuals with uncontrolled epilepsy, central nervous system disorders or a history of mental illness, whose clinical severity may hinder signing informed consent or affect patient compliance with oral medication according to the investigator's judgement
- Organ transplant surgery requiring immunosuppressive therapy
- Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities
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, 1 recruiting
- Recruiting
Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China.
Chengdu, Sichuan, 610042
Qian Peng, 17708130617, lbs402889873@163.com
About this study
In this phase I single-arm clinical study, 20 patients with T4 unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. The study will assess patients' surgical R0 resection rate, pCR or cCR rate, PFS, OS, and related adverse effects of treatment, aiming to explore the feasibility, safety, and efficacy of MR-Linac in the treatment of unresectable locally advanced colon cancer.
Read the detailed description
Pre-specified run-in/feasibility phase. As outlined in the registered protocol, this record includes an initial feasibility (run-in) phase conducted under the same eligibility criteria and intervention as the definitive efficacy/safety phase. The run-in is designed solely to evaluate operational and workflow feasibility. The run-in is not powered for efficacy and will not test efficacy or survival hypotheses.
Pre-specified feasibility thresholds for proceeding include, for example: protocol adherence ≥85-90%, adaptive-plan success ≥80-90%, and accrual feasibility ≥80% of the target. The run-in sample size is capped (≈24 patients), and its endpoints/time frames are listed under Outcome Measures. Meeting these thresholds triggers continuation to the definitive phase without changing the intervention or eligibility.
- Conditions
- Safety and Efficacy
- Being tested
- MR-linac
- Keywords
- MR-Linac, unresectable locally advanced colorectal cancer, neoadjuvant radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-linacRadiation
Patients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| MR-linac | Experimental | Patients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy. Receives: Radiation: MR-linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-linac Treatment Completion Rate
Is adaptive radiotherapy guided by MRI feasible for patients with locally advanced unresectable colon cancer. The feasibility of each patient will be recorded as a binary variable (1=feasible; 0=not feasible). Completion Rate = Number of Completions / Total ITT Enrollment
Measured: 2 years
Clinical complete response (cCR)
Clinical complete response refers to the absence of detectable tumor clinically after treatment. Number of cCR cases/Number of cases completed for follow-up evaluation
Measured: 2 years
Pathological complete response (pCR)
Pathological complete response is defined as the absence of any signs of cancer in tissue samples after treatment. Number of pCR cases / Number of completed surgeries
Measured: 2 years
Secondary outcomes (6)
Toxicity reaction (CTC 4.0 standard）
CTC 4.0, also known as Common Terminology Criteria for Adverse Events version 4.0, is an extensively used classification system for assessing drug toxicity. This system categorizes drug toxicity into five levels: Grade 0, Grade 1, Grade 2, Grade 3, and Grade 4.
Measured: long range
R0 resection rate
During surgery, the R0 resection rate refers to the complete removal of the entire tumor with no residual abnormalities present in the surrounding normal tissue. R0 rate = Number of R0 cases / Total number of surgical procedures performed
Measured: 2 years
Surgical complications
Surgical complications refers to adverse events or problems that arise during or after a surgical procedure. These complications can range from minor issues to serious complications that may have significant consequences for the patient.
Measured: 2 years
Local control rate
Proportion of cases in remission and stable disease after treatment, i.e., proportion of patients who did not experience disease progression.
Measured: 2 years
Disease-free survival
The time from the start of treatment to the first tumor recurrence/metastasis, or death of the subject due to any cause.
Measured: 2 years
Overall survival
Time from the start of the patient's treatment to the patient's death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Apr 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Safety and EfficacyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Peng, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244537
- Sponsor's protocol ID
- SCCHEC-02-2024-017
- Acronym
- UNLACC
- Status last verified
- Sep 2025
- First submitted
- 25 Jan 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.
PubMed 33734139Yoshihara M, Hiyama T, Tanaka S. [Epidemiology of colorectal cancer]. Nihon Naika Gakkai Zasshi. 2007 Feb 10;96(2):200-6. doi: 10.2169/naika.96.200. No abstract available. Japanese.
PubMed 17370582Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Schmoll HJ, Van Cutsem E, Stein A, Valentini V, Glimelius B, Haustermans K, Nordlinger B, van de Velde CJ, Balmana J, Regula J, Nagtegaal ID, Beets-Tan RG, Arnold D, Ciardiello F, Hoff P, Kerr D, Kohne CH, Labianca R, Price T, Scheithauer W, Sobrero A, Tabernero J, Aderka D, Barroso S, Bodoky G, Douillard JY, El Ghazaly H, Gallardo J, Garin A, Glynne-Jones R, Jordan K, Meshcheryakov A, Papamichail D, Pfeiffer P, Souglakos I, Turhal S, Cervantes A. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol. 2012 Oct;23(10):2479-2516. doi: 10.1093/annonc/mds236.
PubMed 23012255Wu C. Systemic Therapy for Colon Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):235-242. doi: 10.1016/j.soc.2017.11.001. Epub 2017 Dec 16.
PubMed 29496087Karoui M, Rullier A, Luciani A, Bonnetain F, Auriault ML, Sarran A, Monges G, Trillaud H, Le Malicot K, Leroy K, Sobhani I, Bardier A, Moreau M, Brindel I, Seitz JF, Taieb J. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial. BMC Cancer. 2015 Jul 10;15:511. doi: 10.1186/s12885-015-1507-3.
PubMed 26156156Chang H, Yu X, Xiao WW, Wang QX, Zhou WH, Zeng ZF, Ding PR, Li LR, Gao YH. Neoadjuvant chemoradiotherapy followed by surgery in patients with unresectable locally advanced colon cancer: a prospective observational study. Onco Targets Ther. 2018 Jan 17;11:409-418. doi: 10.2147/OTT.S150367. eCollection 2018.
PubMed 29398921Tomizawa K, Miura Y, Fukui Y, Hanaoka Y, Toda S, Moriyama J, Inoshita N, Ozaki Y, Takano T, Matoba S, Kuroyanagi H. Curative resection for locally advanced sigmoid colon cancer using neoadjuvant chemotherapy with FOLFOX plus panitumumab: A case report. Int J Surg Case Rep. 2017;31:128-131. doi: 10.1016/j.ijscr.2017.01.027. Epub 2017 Jan 17.
PubMed 28135678Reima H, Soplepmann J, Elme A, Lohmus M, Tiigi R, Uksov D, Innos K. Changes in the quality of care of colorectal cancer in Estonia: a population-based high-resolution study. BMJ Open. 2020 Oct 8;10(10):e035556. doi: 10.1136/bmjopen-2019-035556.
PubMed 33033081Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.
PubMed 23017669Reibetanz J, Germer CT. [Neoadjuvant chemotherapy for locally advanced colon cancer : Initial results of the FOxTROT study.]. Chirurg. 2013 Oct 13. doi: 10.1007/s00104-013-2631-8. Online ahead of print. No abstract available. German.
PubMed 24122133Karoui M, Rullier A, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/collaborators. Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22). Ann Surg. 2020 Apr;271(4):637-645. doi: 10.1097/SLA.0000000000003454.
PubMed 31356278Ryan R, Gibbons D, Hyland JM, Treanor D, White A, Mulcahy HE, O'Donoghue DP, Moriarty M, Fennelly D, Sheahan K. Pathological response following long-course neoadjuvant chemoradiotherapy for locally advanced rectal cancer. Histopathology. 2005 Aug;47(2):141-6. doi: 10.1111/j.1365-2559.2005.02176.x.
PubMed 16045774Huang CM, Huang MY, Ma CJ, Yeh Y-, Tsai HL, Huang CW, Huang CJ, Wang JY. Neoadjuvant FOLFOX chemotherapy combined with radiotherapy followed by radical resection in patients with locally advanced colon cancer. Radiat Oncol. 2017 Mar 7;12(1):48. doi: 10.1186/s13014-017-0790-3.
PubMed 28270172
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT06244537
- Acronym / sponsor ID
- UNLACC / SCCHEC-02-2024-017
- Conditions
- Safety and Efficacy
- Keywords
- MR-Linac, unresectable locally advanced colorectal cancer, neoadjuvant radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2024 (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.
In this phase I single-arm clinical study, 20 patients with T4 unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. The study will assess patients' surgical R0 resection rate, pCR or cCR rate, PFS, OS, and related adverse effects of treatment, aiming to explore the feasibility, safety, and efficacy of MR-Linac in the treatment of unresectable locally advanced colon cancer.
Detailed description
Pre-specified run-in/feasibility phase. As outlined in the registered protocol, this record includes an initial feasibility (run-in) phase conducted under the same eligibility criteria and intervention as the definitive efficacy/safety phase. The run-in is designed solely to evaluate operational and workflow feasibility. The run-in is not powered for efficacy and will not test efficacy or survival hypotheses.
Pre-specified feasibility thresholds for proceeding include, for example: protocol adherence ≥85-90%, adaptive-plan success ≥80-90%, and accrual feasibility ≥80% of the target. The run-in sample size is capped (≈24 patients), and its endpoints/time frames are listed under Outcome Measures. Meeting these thresholds triggers continuation to the definitive phase without changing the intervention or eligibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-linac | Experimental | Radiation: MR-linacPatients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years old
- Patients can remain in a stationary position on the treatment bed for 1-1.5 hours
- ECOG score 0-1
- Pathological diagnosis of colon adenocarcinoma, clinical stage cT4N0-2M0
- Organ function is normal, and the following conditions are required: white blood cell count ≥3.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90g/L. Total bilirubin level ≤1.5× upper limit of normal (ULN); AST and ALT levels ≤2.5 × ULN; endogenous creatinine clearance rate: 56-122ml/min; serum creatinine <1.0× ULN; serum albumin ≥30g/L.
Key exclusion criteria (12 listed)
- Patients with dMMR or MSI-H
- Presence of other types of tumors in addition to colon adenocarcinoma
- Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons
- Distant metastasis (M1)
- Pregnant or lactating women
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 |
|---|---|---|
| MR-linacPatients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy. | Radiation | MR-linac |
Primary outcome
MRI-linac Treatment Completion Rate
Time frame: 2 years
Is adaptive radiotherapy guided by MRI feasible for patients with locally advanced unresectable colon cancer. The feasibility of each patient will be recorded as a binary variable (1=feasible; 0=not feasible). Completion Rate = Number of Completions / Total ITT Enrollment
Clinical complete response (cCR)
Time frame: 2 years
Clinical complete response refers to the absence of detectable tumor clinically after treatment. Number of cCR cases/Number of cases completed for follow-up evaluation
Pathological complete response (pCR)
Time frame: 2 years
Pathological complete response is defined as the absence of any signs of cancer in tissue samples after treatment. Number of pCR cases / Number of completed surgeries
6 secondary outcomes
Toxicity reaction (CTC 4.0 standard）
Time frame: long range
R0 resection rate
Time frame: 2 years
Surgical complications
Time frame: 2 years
Local control rate
Time frame: 2 years
Disease-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
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 9 Sep 2025.
- Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Results publication: PubMed 33734139Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.
- Results publication: PubMed 17370582Yoshihara M, Hiyama T, Tanaka S. [Epidemiology of colorectal cancer]. Nihon Naika Gakkai Zasshi. 2007 Feb 10;96(2):200-6. doi: 10.2169/naika.96.200. No abstract available. Japanese.
- Results publication: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Results publication: PubMed 23012255Schmoll HJ, Van Cutsem E, Stein A, Valentini V, Glimelius B, Haustermans K, Nordlinger B, van de Velde CJ, Balmana J, Regula J, Nagtegaal ID, Beets-Tan RG, Arnold D, Ciardiello F, Hoff P, Kerr D, Kohne CH, Labianca R, Price T, Scheithauer W, Sobrero A, Tabernero J, Aderka D, Barroso S, Bodoky G, Douillard JY, El Ghazaly H, Gallardo J, Garin A, Glynne-Jones R, Jordan K, Meshcheryakov A, Papamichail D, Pfeiffer P, Souglakos I, Turhal S, Cervantes A. ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making. Ann Oncol. 2012 Oct;23(10):2479-2516. doi: 10.1093/annonc/mds236.
- Results publication: PubMed 29496087Wu C. Systemic Therapy for Colon Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):235-242. doi: 10.1016/j.soc.2017.11.001. Epub 2017 Dec 16.
- Results publication: PubMed 26156156Karoui M, Rullier A, Luciani A, Bonnetain F, Auriault ML, Sarran A, Monges G, Trillaud H, Le Malicot K, Leroy K, Sobhani I, Bardier A, Moreau M, Brindel I, Seitz JF, Taieb J. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial. BMC Cancer. 2015 Jul 10;15:511. doi: 10.1186/s12885-015-1507-3.
- Results publication: PubMed 29398921Chang H, Yu X, Xiao WW, Wang QX, Zhou WH, Zeng ZF, Ding PR, Li LR, Gao YH. Neoadjuvant chemoradiotherapy followed by surgery in patients with unresectable locally advanced colon cancer: a prospective observational study. Onco Targets Ther. 2018 Jan 17;11:409-418. doi: 10.2147/OTT.S150367. eCollection 2018.
- Results publication: PubMed 28135678Tomizawa K, Miura Y, Fukui Y, Hanaoka Y, Toda S, Moriyama J, Inoshita N, Ozaki Y, Takano T, Matoba S, Kuroyanagi H. Curative resection for locally advanced sigmoid colon cancer using neoadjuvant chemotherapy with FOLFOX plus panitumumab: A case report. Int J Surg Case Rep. 2017;31:128-131. doi: 10.1016/j.ijscr.2017.01.027. Epub 2017 Jan 17.
- Results publication: PubMed 33033081Reima H, Soplepmann J, Elme A, Lohmus M, Tiigi R, Uksov D, Innos K. Changes in the quality of care of colorectal cancer in Estonia: a population-based high-resolution study. BMJ Open. 2020 Oct 8;10(10):e035556. doi: 10.1136/bmjopen-2019-035556.
- Results publication: PubMed 23017669Foxtrot Collaborative Group. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. Lancet Oncol. 2012 Nov;13(11):1152-60. doi: 10.1016/S1470-2045(12)70348-0. Epub 2012 Sep 25.
- Results publication: PubMed 24122133Reibetanz J, Germer CT. [Neoadjuvant chemotherapy for locally advanced colon cancer : Initial results of the FOxTROT study.]. Chirurg. 2013 Oct 13. doi: 10.1007/s00104-013-2631-8. Online ahead of print. No abstract available. German.
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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 study testing MR-linac in people with Safety and Efficacy, run by Sichuan Cancer Hospital and Research Institute 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 12 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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.
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 Qian - Peng, chief physician (+086 17708130617, pengqian@scszlyy.org.cr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-linac Treatment Completion Rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244537, which also lists 25 linked publications.
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 9 Sep 2025.