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Anus NeoplasmsPhase 3NCT02526953

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

A Phase 3 study testing Paclitaxel, Capecitabine and Mitomycins in people with Anus Neoplasms and Carcinoma, Squamous Cell, run by Blokhin's Russian Cancer Research Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Paclitaxel, Capecitabine and Mitomycins
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
No sites listed yet
Study dates
Jan 2016to Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Platelet Count (PLT) > 120x10*9/L
  • Serum creatinine < 150 µmol/L
  • Total bilirubin < 25 µmol/L

Who cannot join

  • 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
Show all 16Show fewer
  • 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

About this study

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

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.

Read the 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.

Being tested
Paclitaxel, Capecitabine, Mitomycins, Radiotherapy
Keywords
anal cancer, chemoradiation, intensity-modulated radiotherapy, paclitaxel
Medical subject headings
Anus Neoplasms, Carcinoma, Squamous Cell, Anus Diseases, Neoplasms, Neoplasms, Squamous Cell, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called (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

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

  • CapecitabineDrug

    Also called Xeloda

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

  • CapecitabineDrug

    Also called Xeloda

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

  • MitomycinsDrug

    Also called Mitomycin C, MMC

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

  • MitomycinsDrug

    Also called Mitomycin C, MMC

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

  • RadiotherapyRadiation

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

Study groups in NCT02526953
Study groupRoleWhat they receive
PaclitaxelExperimentalPatients 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.
Receives: Drug: Paclitaxel; Drug: Capecitabine; Drug: Mitomycins; Radiation: Radiotherapy
StandardActive comparatorPatients 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.
Receives: Drug: Capecitabine; Drug: Mitomycins; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease-free survival

    Measured: 3 years

Secondary outcomes (6)

  1. Complete response at 26 weeks

    Measured: 26 weeks

  2. 3-year colostomy-free survival

    Measured: 3 years

  3. 3-year cancer-specific survival

    Measured: 3 years

  4. 3-year overall survival

    Measured: 3 years

  5. 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

    Measured: 30 days

  6. Late toxicity measured according to Radiation Therapy Oncology Group (RTOG) criteria

    Late toxicity measured according to RTOG criteria

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02526953
Sponsor's protocol ID
SCAC-001
Status last verified
Feb 2021
First submitted
15 Aug 2015
Last updated
9 Feb 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, Capecitabine and Mitomycins in people with Anus Neoplasms and Carcinoma, Squamous Cell, run by Blokhin's Russian Cancer Research Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.

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