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The effectiveness of the total neoadjuvant therapy in in rectal adenocarcinoma patients

A clinical trial to compare the effectiveness of the total neoadjuvant therapy with standard approach in rectal adenocarcinoma patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220723055527N1
Enrollment
60
Registered
2022-11-07
Start date
2022-12-11
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Rectal adenocarcinoma. Malignant neoplasm of rectum

Interventions

Intervention 1: Intervention group: The intervention group will first receive neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then neoadjuvant chemotherapy with FOLFOX or CapO

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor
Sabzevar University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with rectal adenocarcinoma based on pathological diagnosis The zero to two level of Eastern Cooperative Oncology Group (ECOG) Healthy functioning bone marrow Healthy functioning liver Healthy functioning kidneys

Exclusion criteria

Exclusion criteria: Having simultaneous adenocarcinoma in other areas of the colon Having metastasis History of previous malignancy History of chemotherapy History of pelvic radiotherapy Having inflammatory intestinal disease Having bilateral hip prosthesis Having allergic to 5-fluorouracil and its other derivatives Having allergic to oxaliplatin

Design outcomes

Primary

MeasureTime frame
The pathological complete response. Timepoint: One week after surgery. Method of measurement: Based on surgical pathology report.;Local recurrence. Timepoint: One year after intervention. Method of measurement: Pelvic computed tomography (CT) scan and colonoscopy.;Distant metastasis. Timepoint: One year after intervention. Method of measurement: Abdominal and pelvic CT scan.

Secondary

MeasureTime frame
Complications of treatment. Timepoint: One, two and three weeks after treatment. Method of measurement: Based on the Common Terminology Criteria for Adverse Events (CTCAE).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshteh Foroughi Pordanjani

Mashhad University of Medical Sciences

foroughifrshte@gmail.com+98 51 3833 0626

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026