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Radiation Therapy
Radiotherapy for Colorectal Cancer
Phase 3
Waitlist Available
Led By Eduardo Rosenblatt
Research Sponsored by International Atomic Energy Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Clinical and/or diagnostic image findings consistent with c/uT4 or CRM+ primary rectal Adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization till the end of follow-up (5 years)
Awards & highlights
Study Summary
This trial is testing two different radiation-based strategies to see which is better for treating locally advanced adenocarcinoma of the rectum.
Who is the study for?
This trial is for adults over 18 with locally advanced rectal cancer who are fit for radiation and major surgery, have a life expectancy of more than 6 months, and can follow up. It's not for those with physical impairments, pregnant or breastfeeding women, sigmoid colon cancer patients, psychiatric diagnoses, recurrent or metastatic disease beyond the pelvis.Check my eligibility
What is being tested?
The study compares two neo-adjuvant radiation strategies before surgery in treating rectal cancer. Participants will be randomly assigned to receive either the investigational therapy or conventional treatment to see if one is superior or at least as effective.See study design
What are the potential side effects?
Radiotherapy may cause side effects like skin irritation at the treatment site, fatigue, nausea, diarrhea and an increased risk of developing secondary cancers later in life. The severity varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My rectal cancer is advanced or has spread to nearby tissues.
Select...
My initial cancer treatment was aimed at curing me.
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I am mostly self-sufficient and can undertake treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization till the end of follow-up (5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization till the end of follow-up (5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Biological Effect and Tumour Biology
Health-related Economics
Quality of Life
Side effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Short Course Radiation Followed by ChemotherapyExperimental Treatment1 Intervention
Experimental short course radiation followed by chemotherapy.
Group II: Arm A: Conventional Long Course Chemo-RadiationActive Control1 Intervention
Conventional long course chemo-radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
International Atomic Energy AgencyLead Sponsor
49 Previous Clinical Trials
11,601 Total Patients Enrolled
National Cancer Center, BratislavaUNKNOWN
University of Cape TownOTHER
245 Previous Clinical Trials
540,968 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a physical disability.I am 18 years old or older.My rectal cancer is advanced or has spread to nearby tissues.My initial cancer treatment was aimed at curing me.I am mostly self-sufficient and can undertake treatment.My hemoglobin level is below 8.0 without needing a blood transfusion.I am under 18 years old.I can attend all necessary follow-up appointments.My cancer has spread beyond the pelvic area.My rectal cancer has come back.My cancer is located entirely in the sigmoid colon.My current medications won't interfere with the trial's chemotherapy.My cancer originates in the anal canal.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Conventional Long Course Chemo-Radiation
- Group 2: Arm B: Short Course Radiation Followed by Chemotherapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum amount of radiation a patient can receive during treatment?
"Radiotherapy has been evaluated in multiple clinical trials, so it has received a score of 3."
Answered by AI
Are investigators still looking for new participants for this research?
"This study, according to the latest update on clinicaltrials.gov, is not recruiting patients. The original posting date was September 1st, 2009, but the page was last updated on October 24th, 2011. That being said, there are 2714 other clinical trials that are currently enrolling patients."
Answered by AI
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