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NCT Number: NCT01152710

Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

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

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Key information

Conditions

Resectable Rectal Cancer Clinical Stage II and III Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Oncology

Ljubljana, Slovenia, 1000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Xeloda

Primary outcomes

  1. complete pathological remission rate

    Time frame: 9 weeks

    after pathological examination of resected specimen

Secondary outcomes

  1. the rate of sphincter preservation in low-sited tumours

    Time frame: 9 weeks

    after the operation

  2. toxicity of combined modality treatment (Number of Participants with Adverse Events)

    Time frame: 5 weeks

    During preoperative treatment, patients will be evaluated weekly for acute toxicity and compliance with the protocol. Clinical examination and complete blood count will be performed and body weight was measured. Toxic side effects will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) (version 2.0). Patients will be followed every three month for the first two years after the last cycle of adjuvant chemotherapy and thereafter every six month up to 5th year.

  3. overall downstaging rate

    Time frame: 9 weeks

    after the pathological examination of resected specimen

  4. overall survival

    Time frame: 5 years

    Overall survival is defined as the time from inclusion to the date of death from any cause or to the date of last follow-up.

  5. local control

    Time frame: 5 years

    Local control is defined as the time from inclusion to the date of local recurrence

  6. relapse-free survival

    Time frame: 5 years

    Relapse-free survival iss defined as the time from inclusion to the first occurrence of disease relapse (local or distant), death or date of last follow-up.

  7. long-term rectal and urogenital morbidity

    Time frame: 2 years after the surgery

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2010
First posted
Jun 29, 2010
Registry last updated
Jun 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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