Evaluation of the effect of total neoadjuvant therapy in rectal cancer

Comparison of pathological response rates in long-term chemoradiotherapy versus short-term radiotherapy in the total neoadjuvant treatment of patients with locally advanced rectal cancer in the context of a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251017067655N1

Enrollment

Registered

2025-12-28

Start date

2025-10-16

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: patients initially receive neoadjuvant induction chemotherapy consisting of one of the following regimens—FOLFOX-4, mFOLFOX-6, or CapOx—for 3 to 4 cycles, according

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histopathologic confirmation of rectal adenocarcinoma Clinical stage cT3–T4 and/or presence of MRI-defined positive lymph nodes ECOG performance status of 0–2 Adequate bone marrow function (hemoglobin > 10 g/dL; white blood cell count > 3 × 10?/L; absolute neutrophil count > 1.5 × 10?/L; platelet count > 100 × 10?/L Adequate hepatic function (SGOT and/or SGPT = 3 × the upper limit of normal) Adequate renal function (serum creatinine < 1.6 mg/dL)

Exclusion criteria

Exclusion criteria: Refusal to provide informed consent for study participation Synchronous adenocarcinoma in other segments of the colon Presence of distant metastasis at initial diagnosis History of prior malignancy, except for basal cell carcinoma (BCC) of the skin History of prior chemotherapy History of prior pelvic radiotherapy Inflammatory bowel disease Bilateral hip prostheses

Design outcomes

Primary

Measure	Time frame
Pathologic complete response (pCR): The proportion of patients with no viable tumor cells in the resected rectum and regional lymph nodes following total neoadjuvant therapy and surgery. Timepoint: end of treatment at the time of surgery. Method of measurement: Histopathological evaluation of surgical specimens (TME: APR or LAR) by an experienced pathologist.	—

Secondary

Measure	Time frame
Acute treatment-related toxicities: Including anemia, neutropenia, thrombocytopenia, diarrhea, nausea/vomiting, anorexia, dysuria, and other adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Timepoint: Weekly clinical and laboratory evaluation during radiotherapy and every 2–3 weeks during chemotherapy. Method of measurement: CBC, medical history and physical exam.	—

Measure

Time frame

Acute treatment-related toxicities: Including anemia, neutropenia, thrombocytopenia, diarrhea, nausea/vomiting, anorexia, dysuria, and other adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Timepoint: Weekly clinical and laboratory evaluation during radiotherapy and every 2–3 weeks during chemotherapy. Method of measurement: CBC, medical history and physical exam.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShabnam AshofteBargi

Babol University of Medical Sciences

shabnam.ir@gmail.com+98 11 3525 2730

Outcome results

None listed

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