NCT01382745

Brief Summary

The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

9.7 years

First QC Date

June 24, 2011

Last Update Submit

January 25, 2013

Conditions

Squamous Cell Carcinoma of Anal Canal

Outcome Measures

Primary Outcomes (2)

  • Toxicity

    Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.

    1 month post end of treatment

  • Local tumor response rate

    Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.

    8 weeks post end of radiation treatment

Secondary Outcomes (2)

  • Overall cancer-free survival

    5 years post end of treatment

  • Overall survival

    5 years post end of treatment

Study Arms (1)

Nimotuzumab

EXPERIMENTAL

Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy

Drug: NimotuzumabRadiation: Intensity Modulated Radiation Therapy (IMRT)

Interventions

NimotuzumabDRUG

200mg Nimotuzumab once a week for 12 weeks

Nimotuzumab
Intensity Modulated Radiation Therapy (IMRT)RADIATION

IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions

Nimotuzumab

Eligibility Criteria

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

You may qualify if:

  • For both step I and II:
  • Patients with histologically confirmed squamous cell carcinoma of the anal canal
  • Aged 18 years or older
  • ECOG: 0-1-2
  • Adequate contraception in women of child-bearing potential and for men
  • Ability to understand and the willingness to sign a written informed consent document.
  • HIV-positive patients with T1-2 anal canal tumors, or
  • Patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
  • Patients who have already started radiotherapy for anal canal cancer
  • For step II:
  • HIV-positive patients with T1, T2 anal canal tumors
  • HIV-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
  • HIV-negative patients with T1-2 anal canal cancer

You may not qualify if:

  • For both step I and II:
  • Patients receiving any other investigational agents
  • Previous treatment with anti-EGFR drugs
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study.
  • Previously treated with pelvic radiotherapy.
  • Lesions not suitable for radiotherapy
  • Patients with uncontrolled hypercalcemia
  • Uncontrolled intercurrent illness
  • Pregnant or breast-feeding women
  • Any concurrent active malignancy
  • Patients with T3-4 anal canal tumors or patients with nodes positive.
  • Step I:
  • HIV-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-FU and MMC chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Interventions

nimotuzumabRadiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Te Vuong, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD-Director Radiation Oncology

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 27, 2011

Study Start

January 1, 2012

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

CA(1)