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 : Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : June 28, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||June 25, 2021|
|Estimated Study Completion Date :||December 2021|
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.
- 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
- 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 ]
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
|Institut de Cancérologie de l'Ouest - Centre Paul Papin|
|Centre François Baclesse|
|Caen, France, 14076|
|Centre Léon Berard|
|Centre Antoine Lacassagne|
|Institut de cancérologie de l'Ouest|
|St HERBLAIN, France, 44805|
|Centre Paul Strauss|
|Institut de Cancérologie de Lorraine|
|Vandoeuvre-les-Nancy, France, 54519|
|Principal Investigator:||Carmen FLORESCU, MD||Centre François Baclesse|