Radiotherapy for Rectal Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByNeil Kopek, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must not be taking: Warfarin, Phenytoin, Sorivudine
Disqualifiers: Previous pelvic radiotherapy, Metastatic disease, Cardiorespiratory comorbidity, others
No Placebo Group
Approved in 6 jurisdictions
Trial Summary
What is the purpose of this trial?This trial involves treating patients with rectal cancer using a combination of radiation and chemotherapy. The radiation aims to kill cancer cells, and the chemotherapy makes these cells more sensitive to the radiation. This approach targets patients whose cancer may not respond well to surgery alone.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are taking warfarin, phenytoin, or sorivudine.
What data supports the effectiveness of the treatment Radiotherapy for Rectal Cancer?
External beam radiotherapy (EBRT) has been shown to be effective in treating various cancers, such as prostate cancer, by reducing cancer recurrence and improving survival rates. This suggests that EBRT could also be beneficial for rectal cancer treatment.
12345Is external beam radiotherapy (EBRT) generally safe for humans?
External beam radiotherapy (EBRT) can cause long-term side effects like bowel injury and rectal bleeding, especially when used for prostate and rectal cancers. These side effects are important to consider when evaluating the safety of EBRT.
678910How is radical external beam radiotherapy (EBRT) unique for treating rectal cancer?
Radical external beam radiotherapy (EBRT) is unique because it uses high-energy rays from outside the body to target and kill cancer cells, which is different from treatments like surgery or chemotherapy that involve removing the tumor or using drugs. This method is non-invasive and can be precisely directed at the cancerous area, minimizing damage to surrounding healthy tissue.
12111213Eligibility Criteria
This trial is for adults over 18 with rectal cancer that hasn't spread to other parts of the body. They should be fit enough for surgery, have certain MRI findings like muscle or lymph node involvement, and good organ function. People can't join if they've had pelvic radiation before, have severe bowel issues without a stoma, serious heart/lung problems, another recent cancer (except skin or cervical), specific genetic conditions affecting drug metabolism, are on certain medications, or are pregnant without contraception.Inclusion Criteria
My cancer has spread to the fatty tissue near my rectum.
Ability to comply with oral medication
I am medically cleared for cancer surgery.
+12 more
Exclusion Criteria
I am not fit for the study treatment or surgery.
I have been diagnosed with Gilbert's syndrome.
My cancer is early stage and hasn't spread to my veins.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation and Chemotherapy
Participants receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions, combined with radiosensitizing chemotherapy
6 weeks
Monitoring
Participants are closely monitored through endoscopy and imaging for response to treatment and relapse
Up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests high-dose radiotherapy combined with chemotherapy in rectal cancer patients. The goal is to see if this treatment can allow some patients to avoid surgery by closely monitoring them afterwards and only operating if the cancer doesn't respond completely or comes back locally.
1Treatment groups
Experimental Treatment
Group I: Radical External Beam RT for Colorectal CaExperimental Treatment1 Intervention
A single arm consisting of: Radical external beam RT dose of 54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standard
Radical external beam radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as External Beam Radiation Therapy for:
- Rectal cancer
- Colorectal cancer
- Prostate cancer
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Bladder cancer
- Anal cancer
🇺🇸 Approved in United States as External Beam Radiation Therapy for:
- Rectal cancer
- Colorectal cancer
- Prostate cancer
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Bladder cancer
- Anal cancer
- Breast cancer
- Lung cancer
🇨🇦 Approved in Canada as External Beam Radiation Therapy for:
- Rectal cancer
- Colorectal cancer
- Prostate cancer
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Bladder cancer
- Anal cancer
🇯🇵 Approved in Japan as External Beam Radiation Therapy for:
- Rectal cancer
- Colorectal cancer
- Prostate cancer
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Bladder cancer
- Anal cancer
🇨🇳 Approved in China as External Beam Radiation Therapy for:
- Rectal cancer
- Colorectal cancer
- Prostate cancer
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Bladder cancer
- Anal cancer
🇨🇭 Approved in Switzerland as External Beam Radiation Therapy for:
- Rectal cancer
- Colorectal cancer
- Prostate cancer
- Cervical cancer
- Vulval cancer
- Vaginal cancer
- Bladder cancer
- Anal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McGill University Health Center-Cedars Cancer CentreMontréal, Canada
McGill University Health Centre- Cedars Cancer CentreMontreal, Canada
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Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
References
Radical external beam radiotherapy for clinically localized prostate cancer in Japan: changing trends in the patterns of care process survey. [2019]To delineate changing trends in radical external beam radiotherapy (EBRT) for prostate cancer in Japan.
Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. [2020]External beam radiotherapy (EBRT) is an effective treatment for symptomatic bone metastases from a variety of primary malignancies. Previous meta-analyses and systematic reviews have reported on the efficacy of EBRT on bone metastases from multiple primaries. This review is focused on the comparative effectiveness of single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients.
Impact of High-Dose-Rate and Low-Dose-Rate Brachytherapy Boost on Toxicity, Functional and Cancer Outcomes in Patients Receiving External Beam Radiation Therapy for Prostate Cancer: A National Population-Based Study. [2021]External beam radiation therapy (EBRT) with brachytherapy boost reduces cancer recurrence in patients with prostate cancer compared with EBRT monotherapy. However, randomized controlled trials or large-scale observational studies have not compared brachytherapy boost types directly.
External-beam radiotherapy in the management of carcinoma of the prostate. [2017]External-beam radiotherapy (EBRT) has been used in the treatment of adenocarcinoma of the prostate gland for more than 30 years. Well-documented clinical series have demonstrated the effectiveness of EBRT in achieving both cause-specific survival and freedom from biochemical (prostate-specific antigen [PSA]) progression.
Adjuvant Small Pelvic Radiotherapy in Patients with Cervical Cancer Having Intermediate Risk Factors Only - Is It Sufficient? [2018]We sought to determine the outcomes of adjuvant small pelvic external beam radiotherapy (EBRT) and prognostic factors for survival and disease control.
Curative external beam radiotherapy for prostate carcinoma: results in 231 patients treated in Lyon. [2019]Radical prostatectomy and external beam radiation therapy (EBRT) are the mainstays of treatment of prostate cancer with curative intent. The possible development of radiation proctitis and rectal bleeding are major concerns when using EBRT. Recently, conformal radiotherapy has been introduced in an attempt to improve the results of EBRT. This paper presents an overview of the Lyon experience using standard EBRT with doses of 68 Gy, and reports the preliminary results of a study of conformal radiotherapy with dose escalation.
Pathophysiology of late anorectal dysfunction following external beam radiotherapy for prostate cancer. [2015]Patients treated with external beam radiotherapy (EBRT) may suffer from long-term anorectal adverse effects. The purpose of the present study was to assess long-term functional and structural anorectal changes in patients previously treated with EBRT for prostate cancer and to suggest the mechanism behind the development of the adverse effects.
Predictors of urinary and rectal toxicity after external conformed radiation therapy in prostate cancer: Correlation between clinical, tumour and dosimetric parameters and radical and postoperative radiation therapy. [2019]To determine rectal and urinary toxicity after external beam radiation therapy (EBRT), assessing the results of patients who undergo radical or postoperative therapy for prostate cancer (pancreatic cancer) and their correlation with potential risk factors.
The incidence and clinical consequences of treatment-related bowel injury. [2019]To assess the frequency and clinical features of treatment-induced bowel injury in rectal carcinoma patients receiving perioperative external beam radiotherapy (EBRT). The frequency of and factors associated with treatment-induced intestinal injury have previously not been well quantified for rectal cancer patients. Postoperative adjuvant chemoirradiation is recommended for Stage II and III rectal cancers, making such data of significant interest.
An investigation into the incidence of pain flare in patients undergoing radiotherapy for symptomatic bone metastases. [2018]External Beam Radiotherapy (EBRT) is a recognised intervention for symptomatic pain relief from bone metastases. Pain flare is a reported EBRT toxicity, described in 16-41% of steroid-naïve patients. This study aimed to determine incidence and duration of pain flare amongst patients within one Oncology Centre.
Is there a place for definitive radiotherapy in the treatment of unresectable soft-tissue sarcoma? A systematic review. [2022]Definitive external beam radiotherapy (EBRT) is an unusual treatment of unresectable soft-tissue sarcomas (STS). Recent technical innovations and physical advantages of particle therapies may improve results of this therapeutic option. The role of this review was to report the clinical results of photon- and particle-based EBRT in unresectable STS.
Role of external beam radiotherapy with low-dose-rate brachytherapy in treatment of prostate cancer. [2015]To report a single-institution experience and analysis of the role of supplemental external beam radiotherapy (EBRT) with brachytherapy. EBRT is often used in addition to low-dose-rate brachytherapy in the treatment of prostate cancer, particularly for disease with adverse features.
Fractionated beam radiotherapy is a special case of continuous beam radiotherapy when irradiation time is small. [2018]Fractionated beam radiotherapy, in other terms, external beam radiotherapy (EBRT) and continuous beam radiotherapy or Brachytherapy are two modes of radiotherapy techniques. Although in many ways, they appear to be different, radiobiologically, with the help of mathematics, it can be proved that the biological effective dose (BED) of EBRT is similar to BED of Brachytherapy, when irradiation time is small. Here an attempt is made to correlate these two predominant modes of radiotherapy techniques.