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The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.
This trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either standard IMRT with capecitabine and mitomycin or IMRT with capecitabine, mitomycin and paclitaxel. A stratification will be performed based on T stage, N stage and clinical center. Doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance. The target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging and followup. Pelvic MRI and histological diagnosis are subject to central review. Conduction of this study and data collection are controlled by a local institutional board.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental | Patients will receive intensity-modulated radiotherapy with dose based on T stage. The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of paclitaxel 45 mg/m2 on days 3,10,17,24,31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1. |
|
| Standard | Active Comparator | Patients will receive intensity-modulated radiotherapy with dose based on T stage. The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of capecitabine 825 mg/m2 bid on treatment days and mitomycin C 12 g/m2 on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 45 mg/m2, IV, weekly during the radiation. Number of infusions: 5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response at 26 weeks | 26 weeks | |
| 3-year colostomy-free survival | 3 years | |
| 3-year cancer-specific survival |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life according to European organization for research and treatment of cancer (EORTC) Quality of Life questionnaire (QLQ)-C30 (v.3) scale | Change from baseline in quality of life on the EORTC QLQ-C30 (v.3) scale | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arsen O Rasulov, PhD | N.N.Blokhin Russian Cancer Research Center | Study Chair |
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| Capecitabine | Drug | 625 mg/m2, bid, per os, only on days of radiation (Monday through Friday) |
|
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| Capecitabine | Drug | 825 mg/m2, bid, per os, only on days of radiation (Monday through Friday) |
|
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| Mitomycins | Drug | 10 mg/m2, IV, on day 1. Number of infusions: 1. |
|
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| Mitomycins | Drug | 12 mg/m2, IV, on day 1. Number of infusions: 1. |
|
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| Radiotherapy | Radiation | Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage |
|
| 3 years |
| 3-year overall survival | 3 years |
| Acute toxicity measured according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 | Toxicity measured according to NCI-CTCAE v.4.0 | 30 days |
| Late toxicity measured according to Radiation Therapy Oncology Group (RTOG) criteria | Late toxicity measured according to RTOG criteria | 3 years |
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D001004 | Anus Diseases |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000069287 | Capecitabine |
| D008937 | Mitomycins |
| D016685 | Mitomycin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D001389 | Azirines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |
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