← Back to Search

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
Must not have
Hemoglobin < 8.0 (or 80, SI) without transfusion
Significant development issues (age < 18 yr)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization till the end of follow-up (5 years)
Awards & highlights

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.
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.
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 below
Select...
I am 18 years old or older.
Select...
My rectal cancer is advanced or has spread to nearby tissues.
Select...
My initial cancer treatment was aimed at curing me.
Select...
I am mostly self-sufficient and can undertake treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My hemoglobin level is below 8.0 without needing a blood transfusion.
Select...
I am under 18 years old.
Select...
My cancer has spread beyond the pelvic area.
Select...
My rectal cancer has come back.
Select...
My cancer is located entirely in the sigmoid colon.
Select...
My cancer originates in the anal canal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization till the end of follow-up (5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization till the end of follow-up (5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Biological Effect and Tumour Biology
Health-related Economics

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
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%
Dysphagia-esophageal radiation
8%
Hypoglycemia
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?

National Cancer Center, BratislavaUNKNOWN
V.N. Cancer Center GKNM HospitalUNKNOWN
International Atomic Energy AgencyLead Sponsor
49 Previous Clinical Trials
11,601 Total Patients Enrolled

Media Library

Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01459328 — Phase 3
Colorectal Cancer Research Study Groups: Arm B: Short Course Radiation Followed by Chemotherapy, Arm A: Conventional Long Course Chemo-Radiation
Colorectal Cancer Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT01459328 — Phase 3
Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01459328 — Phase 3
~22 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top