To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer

To evaluate the safety and efficacy of simultaneous integrated boost in neoadjuvant short-course radiotherapy for rectal cancer A phase II clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250702066338N1

Enrollment

Registered

2025-12-13

Start date

2026-01-21

Completion date

Unknown

Last updated

2026-02-02

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

Intervention 1: Intervention group: Short-course radiotherapy will be administered in 5 fractions, delivering 5 Gy per day to the gross tumor and regional lymph nodes (total dose: 25 Gy over 5 consecu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient with stage II and III rectal cancer Diagnosis confirmed by biopsy and pathology assessment Tumor range is 15 cm from anus ECOG= 0-2 Renal and liver and bone marrow with normal function

Exclusion criteria

Exclusion criteria: Distant metastasis at presentation Past history of radiation or surgery in pelvis for rectal cancer The patient with comorbidity Patient's dissatisfaction to participate in the trial

Design outcomes

Primary

Measure	Time frame
Pathologic complete response ratio. Timepoint: 8 weeks after radiotherapy. Method of measurement: Biopsy and pathology assessment.	—

Secondary

Measure	Time frame
Incidence of adverse events. Timepoint: Every week in radiotherapy course then every 3 months for 2 years. Method of measurement: History and physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad mohamadianpanah

Shiraz University of Medical Sciences

mohpanah@gmail.com+98 71 3612 5000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026