---
title: Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
nct_id: NCT01152710
overall_status: COMPLETED
phase: PHASE2
sponsor: Institute of Oncology Ljubljana
study_type: INTERVENTIONAL
primary_condition: Resectable Rectal Cancer Clinical Stage II and III
countries: Slovenia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01152710.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01152710"
ct_last_update_post_date: 2010-06-29
last_seen_at: "2026-05-12T06:54:25.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

**NCT ID:** [NCT01152710](https://clinicaltrials.gov/study/NCT01152710)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 57
- **Lead Sponsor:** Institute of Oncology Ljubljana
- **Conditions:** Resectable Rectal Cancer Clinical Stage II and III
- **Start Date:** 2004-06
- **Completion Date:** 2010-04
- **CT.gov Last Update:** 2010-06-29

## Brief Summary

A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.

## Detailed Description

Preoperative chemoradiation has become a standard part of treatment protocols in stage II and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative application of chemotherapeutics and irradiation includes improved compliance, reduced toxicity and downstaging of the tumour in a substantial number of patients. The latter may enhance the rate of curative surgery, permit sphincter preservation in patients with low-sited tumours and have a positive impact on the quality of life of these patients. Orally administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland) mimics the pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may further enhance its efficacy and tolerability, offering the potential for an enhanced therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally advanced rectal cancer. The primary endpoint of the study is a pathologically determined complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival parameters will be analysed.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* histologically verified adenocarcinoma of the rectum,
* resectable clinical stage II or III (IUCC TNM classification 2002);
* no prior radiotherapy and/or chemotherapy;
* World Health Organisation (WHO) performance status \< 2;
* age at diagnosis of 18 or older;
* and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease).

Exclusion Criteria:

* A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix
```

## Interventions

- **Capecitabine** (DRUG) — Chemotherapy with capecitabine of 1650 mg/m2 daily dose will be administered orally, divided into two equal doses given 12 hours apart, during radiotherapy(45 Gy 1,8 Gy/fr), including weekends

## Primary Outcomes

- **complete pathological remission rate** _(time frame: 9 weeks)_ — after pathological examination of resected specimen

## Secondary Outcomes

- **the rate of sphincter preservation in low-sited tumours** _(time frame: 9 weeks)_
- **toxicity of combined modality treatment (Number of Participants with Adverse Events)** _(time frame: 5 weeks)_
- **overall downstaging rate** _(time frame: 9 weeks)_
- **overall survival** _(time frame: 5 years)_
- **local control** _(time frame: 5 years)_
- **relapse-free survival** _(time frame: 5 years)_
- **long-term rectal and urogenital morbidity** _(time frame: 2 years after the surgery)_

## Locations (1)

- Institute of Oncology, Ljubljana, Slovenia, Slovenia

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.institute of oncology|ljubljana|slovenia|slovenia` — added _(2026-05-12)_

---

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