Resectable Rectal Cancer Clinical Stage II and III Clinical Trial
Official title:
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
| Verified date | June 2010 |
| Source | Institute of Oncology Ljubljana |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Slovenia: Ministry of Health |
| Study type | Interventional |
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | April 2010 |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | Institute of Oncology | Ljubljana |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Oncology Ljubljana |
Slovenia,
Dunst J, Reese T, Sutter T, Zühlke H, Hinke A, Kölling-Schlebusch K, Frings S. Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol. 2002 Oct 1;20(19):3983-91. — View Citation
Jansman FG, Postma MJ, van Hartskamp D, Willemse PH, Brouwers JR. Cost-benefit analysis of capecitabine versus 5-fluorouracil/leucovorin in the treatment of colorectal cancer in the Netherlands. Clin Ther. 2004 Apr;26(4):579-89. — View Citation
Kim JS, Kim JS, Cho MJ, Song KS, Yoon WH. Preoperative chemoradiation using oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):403-8. — View Citation
Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. — View Citation
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Twelves C, Boyer M, Findlay M, Cassidy J, Weitzel C, Barker C, Osterwalder B, Jamieson C, Hieke K; Xeloda Colorectal Cancer Study Group. Capecitabine (Xeloda) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients with advanced colorectal carcinoma. Eur J Cancer. 2001 Mar;37(5):597-604. — View Citation
Velenik V, Anderluh F, Oblak I, Strojan P, Zakotnik B. Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial. Croat Med J. 2006 Oct;47(5):693-700. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | complete pathological remission rate | after pathological examination of resected specimen | 9 weeks | No |
| Secondary | the rate of sphincter preservation in low-sited tumours | after the operation | 9 weeks | No |
| Secondary | toxicity of combined modality treatment (Number of Participants with Adverse Events) | 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. | 5 weeks | Yes |
| Secondary | overall downstaging rate | after the pathological examination of resected specimen | 9 weeks | No |
| Secondary | overall survival | 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 years | No |
| Secondary | local control | Local control is defined as the time from inclusion to the date of local recurrence | 5 years | No |
| Secondary | relapse-free survival | 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. | 5 years | No |
| Secondary | long-term rectal and urogenital morbidity | 2 years after the surgery | No |