Ultra-fractionated Radiotherapy for Rectal Cancer
Recruiting in Palo Alto (17 mi)
Overseen byNina Sanford, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Disqualifiers: Metastatic disease, Prior pelvic RT, Uncontrolled illness, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Ultra-fractionated Radiotherapy for Rectal Cancer?
Research shows that short-course radiation therapy can improve local control of rectal cancer, and similar hypofractionated treatments have been effective in prostate cancer, suggesting potential benefits for rectal cancer as well.
12345Is ultra-fractionated radiotherapy generally safe for humans?
Ultra-fractionated radiotherapy, also known as ultra-hypofractionated radiotherapy, has been studied in prostate and breast cancer treatments and is generally considered safe. Studies have shown that it has acceptable levels of side effects, both in the short term and long term, making it a viable option for patients.
678910How is Ultra-fractionated Radiotherapy for Rectal Cancer different from other treatments?
Ultra-fractionated Radiotherapy for Rectal Cancer is unique because it involves delivering radiation in several small doses multiple times a day, which is different from the traditional approach of fewer, larger doses. This method aims to improve treatment effectiveness and potentially reduce side effects by spreading out the radiation exposure.
1341112Eligibility Criteria
Adults with locally advanced rectal cancer who haven't had previous treatment for it. They must have good organ and bone marrow function, no distant nodal or metastatic disease, and a stable health condition without severe psychiatric illness. Participants need to agree to use contraception during the trial.Inclusion Criteria
Willing and able to provide written informed consent
My cancer is at a stage where it has grown into surrounding tissues or spread to nearby lymph nodes.
T Bili β€ 1.5 x upper limit of normal (ULN);
+16 more
Exclusion Criteria
Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.
Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive dose-escalated hypofractionated adaptive radiotherapy
Up to 60 days
Chemotherapy
Participants receive FOLFOX or CAPOX chemotherapy interdigitated with radiotherapy
Concurrent with radiation
Follow-up
Participants are monitored for safety, effectiveness, and disease progression
1 year
Participant Groups
The trial is testing a new approach called ultra-fractionated radiotherapy combined with chemotherapy in patients with rectal cancer. The goal is to see if this method allows for better control of the disease without surgery.
1Treatment groups
Experimental Treatment
Group I: Phase I Dose CohortsExperimental Treatment1 Intervention
DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis)
Ultrafractionated Radiotherapy for Rectal Cancer is already approved in United States, China, European Union for the following indications:
πΊπΈ Approved in United States as Ultra-fractionated Radiotherapy for:
- Locally Advanced Rectal Cancer
π¨π³ Approved in China as Hypofractionated Radiotherapy for:
- Locally Recurrent Rectal Cancer
πͺπΊ Approved in European Union as Ultra-fractionated Radiotherapy for:
- Rectal Cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT Southwestern Medical CenterDallas, TX
Loading ...
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Neoadjuvant Short-Course Radiation Therapy for Rectal Cancer: Trends and Controversies. [2019]For patients with locally advanced rectal cancer, neoadjuvant hypofractionated short-course radiation remains an underutilized regimen in the USA. We review the current clinical literature highlighting the relative merits of short-course radiation, along with modern neoadjuvant strategies that incorporate its use.
Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial. [2022]The phase 1 portion of this multicenter, phase 1/2 study of hypofractionated (HypoFx) prostate bed radiation therapy (RT) as salvage or adjuvant therapy aimed to identify the shortest dose-fractionation schedule with acceptable toxicity. The phase 2 portion aimed to assess the health-related quality of life (QoL) of using this HypoFx regimen.
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial. [2021]The HYPO-RT-PC trial compared conventionally fractionated radiotherapy with ultra-hypofractionated radiotherapy in patients with localised prostate cancer. Ultra-hypofractionation was non-inferior to conventional fractionation regarding 5-year failure-free survival and toxicity. We aimed to assess whether patient-reported quality of life (QOL) differs between conventional fractionation and ultra-hypofractionation up to 6 years after treatment in the HYPO-RT-PC trial.
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. [2019]Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RT-PC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation.
Short-course preoperative radiation therapy for operable rectal cancer. [2019]Short course neoadjuvant radiation has been shown to provide improved local control of rectal cancer in a clinical trial population even in the presence of standardized surgical techniques. However, this use of hypofractionated radiotherapy has been limited in North America owing to concerns over toxicity.
Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. [2022]Localised prostate cancer is commonly treated with external-beam radiotherapy. Moderate hypofractionation has been shown to be non-inferior to conventional fractionation. Ultra-hypofractionated stereotactic body radiotherapy would allow shorter treatment courses but could increase acute toxicity compared with conventionally fractionated or moderately hypofractionated radiotherapy. We report the acute toxicity findings from a randomised trial of standard-of-care conventionally fractionated or moderately hypofractionated radiotherapy versus five-fraction stereotactic body radiotherapy for low-risk to intermediate-risk localised prostate cancer.
Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. [2023]Ultra-hypofractionation breast radiotherapy is a safe alternative to moderate hypofractionation. This study reports the results of two ultrahypofractionated regimens used in clinical practice in a high-volume radiotherapy center in terms of efficacy and of tolerance.
Hypofractionation for prostate cancer: an update. [2019]Recent advances in image guided radiation therapy (IGRT) has prompted much interest in the use of high-dose-per-fraction regimens for prostate cancer. Furthermore, from a radiobiological standpoint, there is increasing evidence that prostate tumors have a relatively low Ι/Ξ² ratio therefore, the use of hypofractionation may potentially offer acceptable tumor control while minimizing late toxicity to critical structures. Areas covered: This expert review explores the current evidence regarding the safety and efficacy of hypofractionated radiotherapy for prostate cancer. A particular emphasis was placed on large, randomized phase III trials as these are most likely to influence clinical practice. The authors discuss the use of both moderate and extreme hypofractionation. Expert commentary: The recent publication of 5-year outcomes from large prospective trials of moderate hypofractionation enhances our confidence that these techniques are both safe and effective. We recommend the fractionation scheme of 60 Gy in 20 fractions as this regimen was not associated with any notable increase in late toxicity. With respect to extreme hypofractionation, mature phase III trials are needed to demonstrate the safety and efficacy of these techniques. For now, the use of radiosurgery should be limited to participation in prospective clinical trials.
"Give me five" ultra-hypofractionated radiotherapy for localized prostate cancer: non-invasive ablative approach. [2018]Ultra-hypofractionated radiotherapy (RT) is given over a shorter time with larger doses with respect to conventional fractionation in patients with localized prostate cancer (PCa). The use of hypofractionation is supported both from the radiobiological point of view (the low Ξ±/Ξ²-ratio in PCa and dose escalation) and from the rising number of clinical evidences. The aim of this study is to review our data regarding oncological outcomes, namely biochemical progression-free survival (b-PFS) and clinical progression-free survival (c-PFS), acute and long-term toxicities in patients treated with a ultra-hypofractionated RT. A series of 194 patients with clinically localized PCa treated primarily with ultra-hypofractionated RT using image-guided intensity modulated RT (IG-IMRT) at our Institute from 2012 to 2015 was included in this analysis. According to NCCN risk group classification, 65 (33.5%) patients were low risk, 101 (52.1%) intermediate risk, and 28 (14.4%) high risk. Androgen deprivation therapy (ADT) was given to 61 patients (31.4%). A 169 patients (87.1%) received 35 Gy in 5 fractions, while 25 patients (13%) received 32.5 Gy in 5 fractions (usually given in patients with comorbidity). The median duration of the treatment was 10 days (IQR 9-12). Biochemical relapse was defined as a rise of prostate specific antigen (PSA) > 2 ng/ml above nadir. b-PFS, c-PFS, and freedom from gastro-intestinal (GI) and genito-urinary (GU) toxicity curves were calculated by the Kaplan-Meier method. Log-rank test and multivariate Cox models were used to investigate the role RT dose and heterogeneity by NCCN risk groups adjusting for prognostic factors. Data on acute and late term toxicities were collected according to RTOG/EORTC grading system. With a median follow-up of 30 months, 17 patients experienced PSA failure (9%). The 3-year b-PFS was 87% for all patients and rates stratified for the NCCN risk were 94, 82, and 66% for low-, intermediate-, and high-risk groups, respectively. Log-rank tests indicate that biochemical progression was significantly greater for patients with initial PSA (iPSA) greater than 7 ng/ml (P = 0.04), high- and intermediate-risk groups (P = 0.002), low total dose (P = 0.02) and Gleason score (GS) equal or greater than 7 (P = 0.04). No statistically significant association was found with T stage nor ADT. In multivariate analyses, total dose (P = 0.03) and risk groups (P = 0.03) remained significantly associated with recurrence. Acute and late GI and GU toxicity were acceptable. The toxicity of ultra-hypofractionated IG-IMRT in a large clinical cohort of PCa patients was tolerable and confirmed that this treatment is safe and offers excellent tumor control. Moreover, the hypofractionated RT allows to deliver the whole RT over 10 days with a sensible impact in patients' quality of life and potential overall health system and social benefits.
Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. [2023]Prostate cancer might have high radiation-fraction sensitivity, implying a therapeutic advantage of hypofractionated treatment. We present a pre-planned preliminary safety analysis of side-effects in stages 1 and 2 of a randomised trial comparing standard and hypofractionated radiotherapy.
Long-Term Outcomes of a Prospective Study on Highly Hypofractionated Intensity Modulated Radiation Therapy for Localized Prostate Cancer for 3 Weeks. [2023]Reports of radiation therapy for prostate cancer using dose fractions between moderate hypofractionation and ultrahypofractionation are limited. This pilot study involved the application of highly hypofractionated intensity modulated radiation therapy (IMRT) in 15 fractions for 3 weeks and the number of fractions was intermediate between the 2 previously mentioned dose fractions. The long-term outcomes are reported.
Prolonged survival for patients with newly diagnosed, inoperable glioblastoma with 3-times daily ultrafractionated radiation therapy. [2022]Ultrafractionation of radiation therapy is a novel regimen consisting of irradiating tumors several times daily, delivering low doses (