Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

NCT02526953 | Unknown Phase 3

• 1 other identifier: SCAC-001
• Study Type: interventional
• Target: 314
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anus Neoplasms; Carcinoma, Squamous Cell; Anus Diseases; Neoplasms; Neoplasms, Squamous Cell; Carcinoma

Keywords

anal cancer; chemoradiation; intensity-modulated radiotherapy; paclitaxel

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3 years

Secondary Outcomes (6)

• Complete response at 26 weeks

  26 weeks

• 3-year colostomy-free survival

  3 years

• 3-year cancer-specific survival

  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

  30 days

Other Outcomes (1)

• Quality of life according to European organization for research and treatment of cancer (EORTC) Quality of Life questionnaire (QLQ)-C30 (v.3) scale

  3 years

Study Arms (2)

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.

Drug: Paclitaxel; Drug: Capecitabine; Drug: Mitomycins; Radiation: Radiotherapy

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.

Drug: Capecitabine; Drug: Mitomycins; Radiation: Radiotherapy

Interventions

Paclitaxel DRUG

45 mg/m2, IV, weekly during the radiation. Number of infusions: 5.

Also known as: (2α,4α,5β,7β,10β,13α)-4,10-bis(acetyloxy)-13-{[(2R,3S)- 3-(benzoylamino)-2-hydroxy-3-phenylpropanoyl]oxy}- 1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate

Paclitaxel

Capecitabine DRUG

625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

Also known as: Xeloda

Paclitaxel

Mitomycins DRUG

10 mg/m2, IV, on day 1. Number of infusions: 1.

Also known as: Mitomycin C, MMC

Paclitaxel

Radiotherapy RADIATION

Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage

Paclitaxel; Standard

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Histologically verified squamous-cell anal cancer
• Stage I-IIIB (Union for International Cancer Control (UICC) TNM classification v7)
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• HIV (Human Immunodeficiency Virus) negative
• Haemoglobin (HGB) \> 90 g/L
• Platelet Count (PLT) \> 120x10\*9/L
• Serum creatinine \< 150 µmol/L
• Total bilirubin \< 25 µmol/L

You may not qualify if:

• inability to obtain informed consent
• distant metastases
• synchronous or metachronous tumors
• previous chemotherapy or radiotherapy
• clinically significant cardiovascular disorders (myocardial infarction \< 6 months before visit, stroke \< \< 6 months before visit, instable angina \< 3 months before visit, arrhythmia, uncontrolled hypertension \> 160/100 mm hg
• clinically significant neurological disorders
• previous neuropathy 2 or higher
• current infection or heavy systemic disease
• pregnancy, breastfeeding
• ulcerative colitis
• individual intolerance to treatment components
• proven dihydropyrimidine dehydrogenase (DPD) deficiency
• participation in other clinical trials
• psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
• technical inability to perform pelvic MRI

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

MeSH Terms

Conditions

Anus Neoplasms; Carcinoma, Squamous Cell; Anus Diseases; Neoplasms; Neoplasms, Squamous Cell; Carcinoma

Interventions

Paclitaxel; Capecitabine; Mitomycins; Mitomycin; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Arsen O Rasulov, PhD

  N.N.Blokhin Russian Cancer Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2015
• First Posted: August 18, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: February 9, 2021

Record last verified: 2021-02