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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 : October 20, 2021
Sponsor:
Collaborator:
Accuray Incorporated
Information provided by (Responsible Party):
Centre Francois Baclesse

Tracking Information
First Submitted Date  ICMJE December 23, 2015
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Quality of life measured by the Vaizey incontinence scale [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]
  • The acute and late toxicities assessed according the SOMA/LENT scale [ Time Frame: From treatment start to 5 years after the end of radiotherapy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Anal Canal Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
Interventions:
  • Drug: 5Fluorouracile and Mitomycin-C
  • Radiation: Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2020)
71
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2016)
66
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carmen FLORESCU, MD c.florescu@baclesse.unicancer.fr
Contact: Aurélie PARZY, MD a.parzy@baclesse.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02701088
Other Study ID Numbers  ICMJE CANAL-IMRT-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Francois Baclesse
Study Sponsor  ICMJE Centre Francois Baclesse
Collaborators  ICMJE Accuray Incorporated
Investigators  ICMJE
Principal Investigator: Carmen FLORESCU, MD Centre François Baclesse
PRS Account Centre Francois Baclesse
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP