Trials Sponsors Conditions Drugs Pricing

Conditions

Anal Squamous Cell Carcinoma

Keywords

Anal squamous cell carcinomapanitumumabchemoradiationanal cancerGEMCAD-09-02

Outcome Measures

Primary Outcomes (1)

Three-year disease-free survival rate
To estimate the three-year disease-free survival rate in patients treated with 5-FU, mytomicin C and Panitumumab concurrently with radiation therapy as treatment for anal squamous cell carcinoma
3 years

Secondary Outcomes (7)

Disease free survival rate
3 years
Three-year free local-regional failure rate
3 years
Overall survival
3 years
Colostomy-free survival rate
2 years
Complete response rate
3 years
+2 more secondary outcomes

Study Arms (1)

Panitumumab, mytomicin C, 5-FU, radiation

EXPERIMENTAL

Drug: panitumumab, mytomicin C, 5-FU, radiation

Interventions

panitumumab, mytomicin C, 5-FU, radiationDrug

Radiation therapy will be administered concurrent with chemotherapy and Panitumumab treatment. It will start the day 1 of the systemic treatment. That is, the first day of radiation therapy will be the day of the administration of the first dose of Panitumumab and Mitomycin C, as well as the first day of the first 96-hours course of 5-FU continuous infusion. On day 1, drugs and radiation will be administered in the following order: * First, Panitumumab. Panitumumab will be administered by IV infusion on day 1, and every 2 weeks during 8 weeks * Then Mitomycin C, 10mg/m2 on days 1 and 29 * Then start the 5-FU continuous infusion, 1000mg/m2 on days 1-4 and 29-32 * Finally, no less than 2 hours after the start of the 5-FU infusion, first dose of radiation therapy.

Also known as: Vectibix

Panitumumab, mytomicin C, 5-FU, radiation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Man or woman ≥ 18 years
Competent to comprehend, sign, and date an IEC-approved informed consent form

Sponsors & Collaborators

Trial Form Support S.L.
Othercollaborator
Grupo Espanol Multidisciplinario del Cancer Digestivo
Otherlead
Amgen

Study Sites (20)

Hospital Universitario Germans Trias i Pujol. Institut Català Oncologia

Badalona, Barcelona, 08916, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Hospital del Mar

Barcelona, 08003, Spain

Hospital Universitario Vall Hebron

Barcelona, 08035, Spain

Hospital Clínic i Provincial

Barcelona, 08036, Spain

MeSH Terms

Conditions

Anus Neoplasms

Interventions

PanitumumabFluorouracilRadiation

Condition Hierarchy (Ancestors)

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

Study Officials

Jaime Feliu, MD
Hospital Universitario La Paz
STUDY DIRECTOR
Vicente Alonso, MD
Hospital Miguel Servet
PRINCIPAL INVESTIGATOR
Jaume Capdevila, MD
Hospital Universitario Vall Hebron
PRINCIPAL INVESTIGATOR
Ruth Vera, MD
Hospital de Navarra
PRINCIPAL INVESTIGATOR

Enrollment

58 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 28, 2011

Study Start

October 2010

Actual (reported)

Primary Completion

Vectibix for the Treatment of Anal Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Panitumumab, mytomicin C, 5-FU, radiation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Panitumumab, mytomicin C, 5-FU, radiation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations