Locally Advanced Rectal CarcinomaTEHRANNCT05920928
Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer
A study testing Short course radiotherapy with concurrent capecitabine(825mg/m2) and Long course radiotherapy with concurrent capecitabine(825mg/m2) in people with Locally Advanced Rectal Carcinoma, run by Tehran University of Medical Sciences.
Trial summary
Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- What is being tested?
- Short course radiotherapy with concurrent capecitabine(825mg/m2) and Long course radiotherapy with concurrent capecitabine(825mg/m2)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2023to 1 Apr 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge .
Who cannot join
- Familial syndromes e.g. lynch Previous history of cancer Previous history of chemotherapy Recurrent disease Metastatic disease Inability to perform MRI (Claustrophobia or prosthetic valve)
About this study
Official title: Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial
Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.
- Conditions
- Locally Advanced Rectal Carcinoma
- Being tested
- Short course radiotherapy with concurrent capecitabine(825mg/m2), Long course radiotherapy with concurrent capecitabine(825mg/m2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiotherapy with concurrent capecitabine(825mg/m2)Radiation
Also called Short term radiotherapy (25Gy in 5Fr)
Compared to conventional treatments, short-term radiotherapy has lower fraction numbers but higher radiation doses per fraction. capecitabine is given during treatment time (825mg/m2)
Long course radiotherapy with concurrent capecitabine(825mg/m2)Radiation
Also called Long term radiotherapy (50.4Gy in 28Fr)
Long-term radiation is administered in conjunction with concomitant capecitabine (825mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| Long course chemoRadiotherapy (50.4Gy in 28 fr) | Experimental | Neoadjuvant Long course radiotherapy (50.4 Gy in 28 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer Receives: Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2) |
| Short course chemoRadiotherapy (25Gy in 5 fr) | Experimental | Neoadjuvant short course radiotherapy (25 Gy in 5 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer Receives: Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical complete response
At the 18th week following the start of the treatment, the patient will be assessed. The evaluation consist of an MRI and a colonoscopy, with a PET scan being optional.
Measured: Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start23 Sep 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920928
- Sponsor's protocol ID
- IR.TUMS.IKHC.REC. 9911880002
- Acronym
- TEHRAN
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aghili M, Ghalehtaki R, Yaghooti-Khorasani M, Yazdi SMM, Kolahdouzan K. Comparison of the Clinical Response in Total Neoadjuvant Treatment With Long-Term or Short-Term Chemoradiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer (TEHRAN); the Protocol for a Randomized Controlled Clinical Trial. Cancer Med. 2025 Dec;14(24):e71472. doi: 10.1002/cam4.71472.
PubMed 41412957
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05920928
- Acronym / sponsor ID
- TEHRAN / IR.TUMS.IKHC.REC. 9911880002
- Conditions
- Locally Advanced Rectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 23 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 27 Jun 2023 (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.
Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long course chemoRadiotherapy (50.4Gy in 28 fr) | Experimental | Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2)Neoadjuvant Long course radiotherapy (50.4 Gy in 28 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer |
| Short course chemoRadiotherapy (25Gy in 5 fr) | Experimental | Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2)Neoadjuvant short course radiotherapy (25 Gy in 5 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge .
Key exclusion criteria (1 listed)
- Familial syndromes e.g. lynch Previous history of cancer Previous history of chemotherapy Recurrent disease Metastatic disease Inability to perform MRI (Claustrophobia or prosthetic valve)
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 radiotherapy with concurrent capecitabine(825mg/m2)Also: Short term radiotherapy (25Gy in 5Fr)Compared to conventional treatments, short-term radiotherapy has lower fraction numbers but higher radiation doses per fraction. capecitabine is given during treatment time (825mg/m2) | Radiation | Short course chemoRadiotherapy (25Gy in 5 fr) |
| Long course radiotherapy with concurrent capecitabine(825mg/m2)Also: Long term radiotherapy (50.4Gy in 28Fr)Long-term radiation is administered in conjunction with concomitant capecitabine (825mg/m2) | Radiation | Long course chemoRadiotherapy (50.4Gy in 28 fr) |
Primary outcome
Clinical complete response
Time frame: Week
At the 18th week following the start of the treatment, the patient will be assessed. The evaluation consist of an MRI and a colonoscopy, with a PET scan being optional.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 41412957Aghili M, Ghalehtaki R, Yaghooti-Khorasani M, Yazdi SMM, Kolahdouzan K. Comparison of the Clinical Response in Total Neoadjuvant Treatment With Long-Term or Short-Term Chemoradiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer (TEHRAN); the Protocol for a Randomized Controlled Clinical Trial. Cancer Med. 2025 Dec;14(24):e71472. doi: 10.1002/cam4.71472.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Short course radiotherapy with concurrent capecitabine(825mg/m2) and Long course radiotherapy with concurrent capecitabine(825mg/m2) in people with Locally Advanced Rectal Carcinoma, run by Tehran University of Medical Sciences.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Clinical complete response (time frame: Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920928, which also lists 1 linked publication.
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 27 Jun 2023.