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Effect of preoperative chemotherapy in the treatment of patients with locally advanced rectal cancer

Study of efficacy and safety of neoadjuvant chemotherapy with CAPOX regimen and neoadjuvant chemoradiation in complete pathologic responce in locally advanced rectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016082129403N2
Enrollment
40
Registered
2016-09-24
Start date
2016-07-22
Completion date
Unknown
Last updated
2018-02-22

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

All patients will receive one course of chemotherapy with CAPOX regimen consisted of infusional Oxaliplatin 130 mg/m2 first day and oral capecitabine, 2000 mg/m2 twice daily during first to 14th days
Treatment - Other

Sponsors

Vice chancellor for research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pathologically proved adenocarcinoma of the rectum; age 18 years old or older; clinically staged II-III tumor by MRI and/or EUS; ECOG performance status of 0 or 1; no previous history of malignancy, pelvic radiotherapy or chemotherapy; normal or adequate bone marrow reserve; normal or adequate liver and kidney function. Exclusion criteria: patients with distant metastatic disease; prior history of radiation therapy to the pelvis; prior history of chemotherapy for rectal cancer; active connective tissue disease such as scleroderma or Crohn's disease; uncontrolled diabetes mellitus, hypertension or recent cardiovascular disease; significant neuropathy; any previous or recent hypersensitivity or contraindication for chemotherapy agents.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pathological complete response. Timepoint: Before intervention and After surgical resection. Method of measurement: Pathologic examination.

Secondary

MeasureTime frame
Treatment-related side effects. Timepoint: Weekly measurement from the first week to the end of intervention. Method of measurement: According to the Common Terminology Criteria for Adverse Events (version 4.0).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Mohammadian Panah

Shiraz University of Medical Sciences

mirzaies@sums.ac.ir; sepidehmirzaie03@gmail.com; mohpanah@gmail.com+98 71 9361 3511

Outcome results

None listed

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