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Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life (CANAL-IMRT-01)

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ClinicalTrials.gov Identifier: NCT02701088
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Accuray Incorporated
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:

Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is increasing. As epidermoid ACC (95% of ACC) are particularly sensitive to radio and chemotherapy, concomitant radio-chemotherapy is the standard treatment of locally advanced ACC, with proven efficacy on locoregional control, anal sphincter preservation, progression-free survival and complete response rate higher than 80%.

Nevertheless, conventional radiotherapy frequently induces significant non-haematological toxicities requiring treatment interruptions. Thus, treatment usually includes a chemotherapy (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a planned 1-week (or more) interruption and a boost, for a total 54-60 Gy radiation dose over 9 weeks.

Considering the numerous anatomic pelvic structures, ACC has become a localisation of interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.

However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose escalade did not show its interest: 60 Grays remains the standard.

Assuming the deleterious effect of increased overall treatment time on local control and survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the benefit of no irradiation break on ACC tumour control is of interest.

IMRT offers the possibility to deliver different doses to different target volumes simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results were observed with moderate doses and schedules delivering higher doses with short interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.


Condition or disease Intervention/treatment Phase
Locally Advanced Anal Canal Cancer Drug: 5Fluorouracile and Mitomycin-C Radiation: Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Concomitant chemotherapy and radiotherapy
Chemoradiotherapy with two cycles of 5FU and Mitomycin-C plus radiotherapy by SIB-IMRT (for simultaneous integrated boost intensity modulated radiation therapy) day 1 to day 50 in 36 fractions
Drug: 5Fluorouracile and Mitomycin-C
All the patients will receive radiochemotherapy with two cycles of 5FU (1,000 mg/m²/d with 96-h infusion, days 1-5 and 29-33 of SIB-IMRT) and Mitomycin-C (10 mg/m², days 1 and 29).

Radiation: Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy
SIB-IMRT schedule of 61.2 Gy/1.7 Gy to the primary tumor, 57.60 Gy / 1.6 Gy to involved nodes, and 54 / 1.5 Gy to elective pelvic lymph nodes.




Primary Outcome Measures :
  1. Efficacy: The 3-month locoregional control rate [ Time Frame: 3 months after the end of radiotherapy ]
    The 3-month locoregional control rate after the end of IMRT by helical tomotherapy defined by the proportion of patients alive with no local disease progression 3 months after the end of radiotherapy

  2. Tolerance profile: Proportion of patients with no significant toxicities responsible for irradiation breaks [ Time Frame: Until 11 weeks after treatment start ]
    Tolerance profile: Proportion of patients with no significant (grade ≥3 according to NCI CTCAE v4.03) toxicities responsible for irradiation breaks


Secondary Outcome Measures :
  1. Quality of life measured by the EORTC QLQ-C30 (version 3.0) [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]
  2. The acute and late toxicities assessed according to NCI CTCAE v4.03 [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]
  3. The 6- and 12-month locoregional control rates defined by the proportion of patients with no local disease progression at 6 and 12 months after the end of radiotherapy [ Time Frame: at 6 and 12 months after the end of radiotherapy ]
  4. Duration of response defined by the time elapsed from first objective response to progression or death from any cause [ Time Frame: From months 3 to progression ]
  5. Quality of life measured by the additional colorectal module QLQ-CR 29 [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]
  6. Quality of life measured by the Vaizey incontinence scale [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]
  7. The acute and late toxicities assessed according the SOMA/LENT scale [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • WHO performance status ≤ 2
  • Age > 18 years
  • Epidermoid anal canal carcinoma histologically proven, locally advanced with an indication of radiation of pelvic and inguinal nodes concomitantly to chemotherapy
  • The T corresponds to the larger dimension of tumor at the rectal examination and the N is assessed by imaging pelvic MRI-imaging, CT-scan, optionally PET-CT). Eligible tumors are: T2 more than 4 cm N0-N3, T2-T4 N1-N3 or usN1, T3-T4 N0, M0 according to the 6th edition of the American Joint Committee on cancer staging manual.
  • Laboratory data obtained ≤ 14 days prior to registration on study, with adequate bone marrow, hepatic and renal function defined as follows: hemoglobinemia, neutrophil, platelet counts, bilirubin and creatinin level
  • Informed consent form

Exclusion Criteria:

  • Previous invasive cancer within 5 years except basocellular cancer and in situ cervical cancer
  • Tumors with predominant skin involvement
  • Presence of metastases
  • History of pelvic irradiation
  • Contraindication to radiotherapy or chemotherapy
  • Known HIV positive patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701088


Contacts
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Contact: Carmen FLORESCU, MD c.florescu@baclesse.unicancer.fr
Contact: Aurélie PARZY, MD a.parzy@baclesse.unicancer.fr

Locations
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France
Institut de Cancérologie de l'Ouest - Centre Paul Papin Not yet recruiting
Angers, France
Contact: Emmanuel André RIO, MD         
Principal Investigator: Emmanuel RIO, MD         
Sub-Investigator: Amaury PAUMIER, MD         
Sub-Investigator: Nathalie MESGOUEZ-NEBOUT, MD         
Sub-Investigator: Adele MARQUIS, MD         
Sub-Investigator: Hadji HAMIDOU, MD         
Sub-Investigator: Patrice CELLIER, MD         
Sub-Investigator: Julien BLANCHECOTTE, MD         
Sub-Investigator: Pierre TREMOLIERES, MD         
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: Camen FLORESCU, MD       c.florescu@baclesse.unicancer.fr   
Contact: Aurelie PARZY, MD       a.parzy@baclesse.unicancer.fr   
Principal Investigator: Carmen FLORESCU, MD         
Sub-Investigator: Aurélie PARZY, MD         
Sub-Investigator: Marie-Pierre GALAIS, MD         
Sub-Investigator: Claude M'VONDO, MD         
Sub-Investigator: Stephane CORBINAIS, MD         
Sub-Investigator: Mélanie DOS SANTOS, MD         
Centre Oscar Lambret Not yet recruiting
Lille, France
Contact: Xavier MIRABEL, MD         
Principal Investigator: Xavier MIRABEL, MD         
Sub-Investigator: Antoine CARLIER, MD         
Sub-Investigator: Farid EL HAJBI, MD         
Sub-Investigator: Diane PANNIER, MD         
Sub-Investigator: Fredrik LAESTADIUS, MD         
Sub-Investigator: Aurélien CARNOT, MD         
Centre Léon Berard Not yet recruiting
Lyon, France
Contact: Isabelle MARTEL-LAFAY, MD         
Principal Investigator: Isabelle MARTEL-LAFAY, MD         
Sub-Investigator: Severine RACADOT, MD         
Centre Antoine Lacassagne Not yet recruiting
Nice, France
Contact: Karine BENEZERY, MD         
Principal Investigator: Karine BENEZERY, MD         
Sub-Investigator: Alexander FALK, MD         
Sub-Investigator: Eric FRANCOIS, MD         
Sub-Investigator: Ludovic EVESQUE, MD         
Sub-Investigator: Gerard CAVAGLIONE, MD         
Institut de cancérologie de l'Ouest Recruiting
St HERBLAIN, France, 44805
Contact: Emmanuel RIO, MD         
Principal Investigator: Emmanuel RIO, MD         
Sub-Investigator: Charlotte DEMOOR, MD         
Sub-Investigator: Valentine GUIMAS, MD         
Sub-Investigator: Vincent LIBOIS, MD         
Centre Paul Strauss Not yet recruiting
Strasbourg, France
Contact: Georges NOEL, PhD         
Principal Investigator: Georges NOEL, PhD         
Sub-Investigator: Audrey KELLER, MD         
Sub-Investigator: Catherine SCHUMACHER, MD         
IUCT-Oncopole Not yet recruiting
Toulouse, France
Contact: Françoise IZAR, MD         
Principal Investigator: Françoise IZAR, MD         
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-les-Nancy, France, 54519
Contact: Didier PEIFFERT, MD         
Principal Investigator: Didier PEIFFERT, MD         
Sub-Investigator: Maria JOLNEROVSKI, MD         
Sponsors and Collaborators
Centre Francois Baclesse
Accuray Incorporated
Investigators
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Principal Investigator: Carmen FLORESCU, MD Centre François Baclesse

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02701088     History of Changes
Other Study ID Numbers: CANAL-IMRT-01
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors