NCT03381352

Brief Summary

The purpose of this study is to evaluate the efficacy and adverse events of intensity modulated radiation therapy (IMRT) concurrent with chemotherapy for anal squamous carcinoma. All enrolled anal squamous carcinoma patients are intented to receive IMRT concurrent with Capecitabine + mitomycin ± cetuximab targeted therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

December 13, 2017

Last Update Submit

January 28, 2018

Conditions

Anal Cancer

Keywords

RadiotherapyAnal cancerIMRT

Outcome Measures

Primary Outcomes (1)

  • Response rate

    To evaluate response rate of IMRT with chemotherapy

    8 weeks after IMRT

Secondary Outcomes (1)

  • Adverse events

    from start of IMRT to 8 weeks after IMRT

Study Arms (1)

Chemo-radiotherapy with IMRT technique

EXPERIMENTAL

Radiotherapy with IMRT technique concurrent with Capecitabine and MMC chemotherapy

Radiation: Chemo-radiotherapy with IMRT techniqueDrug: CapecitabineDrug: Mitomycin C

Interventions

Chemo-radiotherapy with IMRT techniqueRADIATION

IMRT radiation technique; 50.4-54Gy/25F

Chemo-radiotherapy with IMRT technique
CapecitabineDRUG

Capecitabine 825mg/m2 PO BID

Chemo-radiotherapy with IMRT technique
Mitomycin CDRUG

Mitomycin C 10mg/m2 D1,29 iv

Chemo-radiotherapy with IMRT technique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CT/MRI diagnosed stage cT1-4N0-3;
  • Histologically confirmed anal squamous carcinoma;
  • KPS \>= 70
  • Adequate organ function;
  • No previous radiotherapy or chemotherapy;
  • No surgery.

You may not qualify if:

  • Previous malignant cancer history;
  • Allegic to 5-fu or MMC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Interventions

CapecitabineMitomycin

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Ning Li, MD

CONTACT

0086-13810381399lee_ak@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 22, 2017

Study Start

December 2, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2020

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)