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

Neoplasms Clinical Trial

Official title:

Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02526953
• Other study ID #: SCAC-001
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: October 2022

Study information

• Verified date: February 2021
• Source: Blokhin's Russian Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 314
• Est. completion date: October 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anus Diseases
• Anus Neoplasms
• Carcinoma
• Carcinoma, Squamous Cell
• Neoplasms
• Neoplasms, Squamous Cell

Intervention

Drug:
• Paclitaxel
45 mg/m2, IV, weekly during the radiation. Number of infusions: 5.
• Capecitabine
625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
• Capecitabine
825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
• Mitomycins
10 mg/m2, IV, on day 1. Number of infusions: 1.
• Mitomycins
12 mg/m2, IV, on day 1. Number of infusions: 1.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	3-year disease-free survival		3 years
Secondary	Complete response at 26 weeks		26 weeks
Secondary	3-year colostomy-free survival		3 years
Secondary	3-year cancer-specific survival		3 years
Secondary	3-year overall survival		3 years
Secondary	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
Secondary	Late toxicity measured according to Radiation Therapy Oncology Group (RTOG) criteria	Late toxicity measured according to RTOG criteria	3 years