Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02526953
Recruitment Status : Enrolling by invitation
First Posted : August 18, 2015
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sergey Gordeyev, Blokhin's Russian Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Anus Neoplasms Carcinoma, Squamous Cell Anus Diseases Neoplasms Neoplasms, Squamous Cell Carcinoma Drug: Paclitaxel Drug: Capecitabine Drug: Mitomycins Radiation: Radiotherapy Phase 3

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Paclitaxel
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
45 mg/m2, IV, weekly during the radiation. Number of infusions: 5.
Other Name: (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

Drug: Capecitabine
625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Other Name: Xeloda

Drug: Mitomycins
10 mg/m2, IV, on day 1. Number of infusions: 1.
Other Names:
  • Mitomycin C
  • MMC

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

Active Comparator: Standard
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
825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Other Name: Xeloda

Drug: Mitomycins
12 mg/m2, IV, on day 1. Number of infusions: 1.
Other Names:
  • Mitomycin C
  • MMC

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




Primary Outcome Measures :
  1. 3-year disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Complete response at 26 weeks [ Time Frame: 26 weeks ]
  2. 3-year colostomy-free survival [ Time Frame: 3 years ]
  3. 3-year cancer-specific survival [ Time Frame: 3 years ]
  4. 3-year overall survival [ Time Frame: 3 years ]
  5. Acute toxicity measured according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0 [ Time Frame: 30 days ]
    Toxicity measured according to NCI-CTCAE v.4.0

  6. Late toxicity measured according to Radiation Therapy Oncology Group (RTOG) criteria [ Time Frame: 3 years ]
    Late toxicity measured according to RTOG criteria


Other Outcome Measures:
  1. Quality of life according to European organization for research and treatment of cancer (EORTC) Quality of Life questionnaire (QLQ)-C30 (v.3) scale [ Time Frame: 3 years ]
    Change from baseline in quality of life on the EORTC QLQ-C30 (v.3) scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • inability of long-term followup of the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526953


Sponsors and Collaborators
Blokhin's Russian Cancer Research Center
Investigators
Layout table for investigator information
Study Chair: Arsen O Rasulov, PhD N.N.Blokhin Russian Cancer Research Center

Layout table for additonal information
Responsible Party: Sergey Gordeyev, Principal Investigator, Blokhin's Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT02526953     History of Changes
Other Study ID Numbers: SCAC-001
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Sergey Gordeyev, Blokhin's Russian Cancer Research Center:
anal cancer
chemoradiation
intensity-modulated radiotherapy
paclitaxel
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Anus Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Anus Diseases
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Capecitabine
Mitomycins
Mitomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic