Evaluation of the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer

Evaluation of the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer: a before-after clinical trial without control group

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N431

Enrollment

Registered

2022-06-19

Start date

2022-07-06

Completion date

Unknown

Last updated

2022-06-27

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 sigmoid colon

Interventions

Intervention group: Combination therapy of concomitant chemoradiotherapy includes: radiotherapy with 18 MV photon and total dose of radiotherapy 45 to 50.4 Gy in 25 to 28 sessions plus chemotherapy wi

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age 18 to 75 years Advanced localized rectal cancer Normal liver, kidney and bone marrow condition

Exclusion criteria

Exclusion criteria: Previous chemotherapy Former pelvic radiotherapy Existence of distant metastasis

Design outcomes

Primary

Measure	Time frame
The rate of complete pathological response in surgery. Timepoint: 6 to 8 weeks after the end of the intervention. Method of measurement: By pathological evaluation.;Local recurrence rate. Timepoint: Every 3 to 6 months up to 2 years after the end of the intervention. Method of measurement: By measuring tumor marker CEA and colonoscopy and pelvic CT scan.;Presence of distant metastasis. Timepoint: Every 3 to 6 months up to 2 years after the end of the intervention. Method of measurement: By CT scan of the chest and abdomen.;Overall survival rate. Timepoint: Up to 2 years after the end of the intervention. Method of measurement: By taking a history.	—

Measure

Time frame

The rate of complete pathological response in surgery. Timepoint: 6 to 8 weeks after the end of the intervention. Method of measurement: By pathological evaluation.;Local recurrence rate. Timepoint: Every 3 to 6 months up to 2 years after the end of the intervention. Method of measurement: By measuring tumor marker CEA and colonoscopy and pelvic CT scan.;Presence of distant metastasis. Timepoint: Every 3 to 6 months up to 2 years after the end of the intervention. Method of measurement: By CT scan of the chest and abdomen.;Overall survival rate. Timepoint: Up to 2 years after the end of the intervention. Method of measurement: By taking a history.

—

Secondary

Measure	Time frame
Possible acute and chronic hematologic and non-hematologic complications. Timepoint: up to 2 years after the end of the intervention during patient follow-up. Method of measurement: By taking history, clinical examination and blood test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMandana Biniaz

Hamedan University of Medical Sciences

mandana.biniaz.med@gmail.com+98 81 3838 0572

Outcome results

None listed

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