Locally Advanced Anal Canal CancerPhase 2CANAL-IMRT-01NCT02701088
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
A Phase 2 study testing 5Fluorouracile and Mitomycin-C and Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy in people with Locally Advanced Anal Canal Cancer, run by Centre Francois Baclesse at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Anal Canal Cancer
- What is being tested?
- 5Fluorouracile and Mitomycin-C and Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 8 sitesFrance
- Study dates
- Dec 2015to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Institut de Cancérologie de l'Ouest - Centre Paul Papin
Angers
Centre François Baclesse
Caen, 14076
Centre Léon Berard
Lyon
Centre Antoine Lacassagne
Nice
Institut de cancérologie de l'Ouest
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg
IUCT-Oncopole
Toulouse
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
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
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.
Read more
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.
- Conditions
- Locally Advanced Anal Canal Cancer
- Being tested
- 5Fluorouracile and Mitomycin-C, Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5Fluorouracile and Mitomycin-CDrug
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).
Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| Concomitant chemotherapy and radiotherapy | Experimental | 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 Receives: Drug: 5Fluorouracile and Mitomycin-C; Radiation: Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: The 3-month Locoregional Control Rate
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
Measured: 3 months after the end of radiotherapy
Tolerance Profile: Proportion of Patients With no Significant Toxicities Responsible for Irradiation Breaks
Tolerance profile: Proportion of patients with no significant (grade ≥3 according to NCI CTCAE v4.03) toxicities responsible for irradiation breaks
Measured: Until 11 weeks after treatment start
Secondary outcomes (7)
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
The EORTC QLQ-C30 is a cancer-specific health-related quality of life questionnaire comprising 30 items. It assesses five functional domains (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/quality of life scale, and several single-item symptom measures. Scores are linearly transformed to a 0-100 scale; higher functional and global health scores indicate better functioning/quality of life, whereas higher symptom scores indicate greater symptom burden.
Measured: 6 months after treatment start
The Acute and Late Toxicities Assessed According to NCI CTCAE v4.03
Acute toxicity is defined as toxicity observed within 3 months after treatment initiation. Late toxicity is defined as toxicity observed 3 months after treatment initiation. Here we described the number of patients who observed acute and late toxicities. Details will be given in adverse events description.
Measured: From treatment start to 24 months 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
Measured: 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
Measured: From months 3 to progression
Quality of Life Measured by the Additional Colorectal Module QLQ-CR 29
The EORTC QLQ-CR29 is a colorectal cancer-specific quality of life module designed to complement the QLQ-C30. It assesses disease- and treatment-related symptoms and functional issues, including urinary frequency, blood and mucus in stool, stool frequency, body image, anxiety, sexual function, and other gastrointestinal and treatment-related symptoms. Scores are linearly transformed to a 0-100 scale; higher functional scores indicate better functioning, whereas higher symptom scores indicate greater symptom burden.
Measured: 6 months after treatment start
Quality of Life Measured by the Vaizey Incontinence Scale
Vaizey Score (St. Mark's Incontinence Score): a validated instrument used to assess anal sphincter function and the severity of fecal incontinence. The scale evaluates the frequency of incontinence to gas, liquid, and solid stool, the need to wear pads, use of constipating medication, and lifestyle alterations. Scores range from 0 to 24, with higher scores indicating worse continence and greater impairment of sphincter function.
Measured: 6 months after treatment start
The Acute Toxicities Assessed According the SOMA/LENT Scale
The Subjective SOMA/LENT (Late Effects on Normal Tissues - Subjective, Objective, Management, and Analytic) scale assesses patient-reported late radiation toxicity across multiple symptom domains. Each symptom item (e.g., stool frequency, urinary frequency, vaginal dryness, dyspareunia) is scored separately on a 5-point ordinal scale ranging from 0 to 4, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms, and 4 = very severe or disabling symptoms. Higher scores indicate worse late radiation-related toxicity. No overall total score was calculated; each symptom domain is reported separately.
Measured: At 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startDec 2015
- Primary completion25 Jun 2021
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Locally Advanced Anal Canal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Accuray Incorporated
- Responsible party
- Sponsor
- Investigators
- Carmen FLORESCU, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701088
- Sponsor's protocol ID
- CANAL-IMRT-01
- Acronym
- CANAL-IMRT-01
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2015
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02701088
- Acronym / sponsor ID
- CANAL-IMRT-01 / CANAL-IMRT-01
- Conditions
- Locally Advanced Anal Canal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Accuray Incorporated
- Study start
- Dec 2015 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concomitant chemotherapy and radiotherapy | Experimental | Drug: 5Fluorouracile and Mitomycin-C, Radiation: Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapyChemoradiotherapy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5Fluorouracile and Mitomycin-CAll 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). | Drug | Concomitant chemotherapy and radiotherapy |
| Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapySIB-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. | Radiation | Concomitant chemotherapy and radiotherapy |
Primary outcome
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
7 secondary outcomes
Quality of Life Measured by the EORTC QLQ-C30 (Version 3.0)
Time frame: 6 months after treatment start
The Acute and Late Toxicities Assessed According to NCI CTCAE v4.03
Time frame: From treatment start to 24 months 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: 6 months after treatment start
Quality of Life Measured by the Vaizey Incontinence Scale
Time frame: 6 months after treatment start
The Acute Toxicities Assessed According the SOMA/LENT Scale
Time frame: At 3 months after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Anal Canal Cancer
Recruiting
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
Malignant Neoplasm of Anal Canal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen FLORESCU, MD principal investigator
Centre François Baclesse
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5Fluorouracile and Mitomycin-C and Simultaneously integrated boost of intensity modulated radiation therapy (SIB-IMRT) by tomotherapy in people with Locally Advanced Anal Canal Cancer, run by Centre Francois Baclesse at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: The 3-month Locoregional Control Rate (time frame: 3 months after the end of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.