Locally Advanced Rectal CarcinomaPhase 2NCT05622357
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
A Phase 2 study testing short course radiation therapy followed by 6 cycles of CAPOX then surgery in people with Locally Advanced Rectal Carcinoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- What is being tested?
- short course radiation therapy followed by 6 cycles of CAPOX then surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2018to 1 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological proof of rectal adenocarcinoma.
- Tumors located within 15 cm and not less than 4 cm from anal verge.
- Age: ≥ 18 years.
- Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
- ECOG Performance Status: 0-2.
Who cannot join
- Non-epithelial rectal malignancy such as sarcoma or lymphoma.
- Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
- Recurrent rectal cancer.
- Previous history of malignancy within the last 5 years.
- Previous pelvic irradiation.
- Psychiatric or addictive disorder that would preclude study therapy.
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- Concurrent uncontrolled medical conditions.
- Pregnancy or breast feeding.
- Any contraindication to surgery.
- Extensive peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:
- Is total neoadjuvant treatment in this design safe \& tolerable?
- Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
Read the detailed description
Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks
- Conditions
- Locally Advanced Rectal Carcinoma
- Being tested
- short course radiation therapy followed by 6 cycles of CAPOX then surgery
- Keywords
- advanced rectal cancer- short course radiation - chemotherapy-surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short course radiation therapy followed by 6 cycles of CAPOX then surgeryRadiation
Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery
| Study group | Role | What they receive |
|---|---|---|
| Short course RT followed by full course of chemotherapy then surgery | Experimental | Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery. Receives: Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR)
No residual disease in surgical specimen
Measured: within 30 days
clinical complete response(cCR)
No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy
Measured: within 30 days
Sphincter saving surgery
Patients who were deemed abdomino-perineal resection before treatment start \& were able to undergo low anterior resection after end of treatment
Measured: within 6 months
Secondary outcomes (3)
Local control
defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.
Measured: 3 years
Overall survival
defined as period from diagnosis till last follow up or death from any cause
Measured: 3 years
Disease free survival
defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure or distant failure, whichever comes first.
Measured: within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start18 Mar 2018
- Primary completion20 Dec 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Anwar, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622357
- Sponsor's protocol ID
- 201617097
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05622357
- Acronym / sponsor ID
- 201617097
- Conditions
- Locally Advanced Rectal Carcinoma
- Keywords
- advanced rectal cancer- short course radiation - chemotherapy-surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 18 Nov 2022 (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.
The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:
- Is total neoadjuvant treatment in this design safe \& tolerable?
- Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
Detailed description
Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short course RT followed by full course of chemotherapy then surgery | Experimental | Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgeryShort course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histopathological proof of rectal adenocarcinoma.
- Tumors located within 15 cm and not less than 4 cm from anal verge.
- Age: ≥ 18 years.
- Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
- ECOG Performance Status: 0-2.
Key exclusion criteria (10 listed)
- Non-epithelial rectal malignancy such as sarcoma or lymphoma.
- Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
- Recurrent rectal cancer.
- Previous history of malignancy within the last 5 years.
- Previous pelvic irradiation.
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 |
|---|---|---|
| short course radiation therapy followed by 6 cycles of CAPOX then surgeryShort course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery | Radiation | Short course RT followed by full course of chemotherapy then surgery |
Primary outcome
pathological complete response (pCR)
Time frame: within 30 days
No residual disease in surgical specimen
clinical complete response(cCR)
Time frame: within 30 days
No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy
Sphincter saving surgery
Time frame: within 6 months
Patients who were deemed abdomino-perineal resection before treatment start \& were able to undergo low anterior resection after end of treatment
3 secondary outcomes
Local control
Time frame: 3 years
Overall survival
Time frame: 3 years
Disease free survival
Time frame: within 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing short course radiation therapy followed by 6 cycles of CAPOX then surgery in people with Locally Advanced Rectal Carcinoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Nov 2022. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (pCR) (time frame: within 30 days). 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?
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 18 Nov 2022.