Investigating the clinical response rate of patients with lower rectal cancer after combined treatment with intensity-modulated chemoradiotherapy and pre-surgical chemotherapy

Evaluating the rate of complete clinical response following total neoadjuvant therapy by using chemoradiotherapy by Intensity modulated radiation therapy with simultaneous integrated boost (IMRT-SIB) in patients with lower rectal cancer; a Phase II randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150929024266N6

Enrollment

Registered

2024-02-24

Start date

2024-01-06

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer. Malignant neoplasm of rectum

Interventions

The target population is people over 18 years of age with non-metastatic rectal cancer that are less than 5 cm from the anus and have good clinical conditions.Patients undergoing radiotherapy using 25

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Non-metastatic rectal cancer (>T2N0) that is less than 5 cm from the anal wedge

Exclusion criteria

Exclusion criteria: Inability to do MRI (whether mechanical or claustrophobia) Lack of proper MRI for disease staging Multiple comorbidities Inadequate blood, kidney, or liver indices for the possibility of receiving chemotherapy History of previous malignancies in the pelvis or other areas of the intestine, history of previous surgeries or radiotherapy in the pelvic area MSI-H patients who are candidates for immunotherapy History of IBD or FAP and other colon polyposis syndromes Active malignancies in other areas of the body.

Design outcomes

Primary

Measure	Time frame
The rate of clinical response in MRI and colonoscopy. Timepoint: 12 to 16 weeks after completion of treatment. Method of measurement: Reduction in size or complete disappearance of mass in MRI and colonoscopy.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Ghalehtaki

Tehran University of Medical Sciences

r-ghaletaki@student.tums.ac.ir+98 21 6119 2520

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026