Trial Outcomes & Findings for Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus (NCT NCT01581840)
NCT ID: NCT01581840
Last Updated: 2024-07-01
Results Overview
Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee: * In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used; * in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
8 weeks evaluations after the end of the treatment by radiochemotherapy
Results posted on
2024-07-01
Participant Flow
Between January 2016 and November 2017 (Phase II), 45 patients were enrolled by 15 french centers
Participant milestones
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus
Baseline characteristics by cohort
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 Participants
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
60.19 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks evaluations after the end of the treatment by radiochemotherapyComplete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee: * In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used; * in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint
Outcome measures
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 Participants
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Percentage of Patients With Complete Response to Treatment
Complete response
|
30 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Partial response
|
10 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Stability
|
0 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Progression
|
4 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Death before the evaluation
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 weeks after the end of the treatement by radiotherapyComplete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance according to the investigator's opinion
Outcome measures
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=44 Participants
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Percentage of Patients With Complete Response to Treatment
Complete response
|
27 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Partial response
|
9 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Stability
|
1 Participants
|
|
Percentage of Patients With Complete Response to Treatment
Progression
|
7 Participants
|
SECONDARY outcome
Timeframe: At 3 years after inclusionIt was defined as the time from inclusion to the date of colostomy or death (from any cause). Patients alive without colostomy were censored at date of last news. If a patient had a shunt colostomy and continuity wasrestored, the patient was counted among the patients without a colostomy.
Outcome measures
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 Participants
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
3 Years Colostomy-free Survival (CFS)
|
68.8 % of patients Colostomy-free at 3 years
Interval 53.1 to 80.2
|
SECONDARY outcome
Timeframe: At 3 years after inclusionIt was defined as the time from inclusion to the date of first recurrence (local, regional, metastatic and second anal cancer) or death. Patients alive without recurrence were censored at date of last news.
Outcome measures
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 Participants
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Recurrence-free Survival (RFS) at 3 Years
|
62.2 % of pts with Reccurence-free at 3 yrs
Interval 46.5 to 74.6
|
SECONDARY outcome
Timeframe: At 12 months after inclusionThe percentage was evaluated at 12 months using the Kaplan Meier estimation. In the safety part all the death collected during the study will be reported.
Outcome measures
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 Participants
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Overall Survival (OS) at 12 Months
|
95.6 % of patients alive at 12 months
Interval 83.5 to 99.7
|
Adverse Events
5Fu-mitomycine-panitumumab + Radiotherapy
Serious events: 14 serious events
Other events: 45 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 participants at risk
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Reproductive system and breast disorders
Vaginal fistula
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
5/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Small bowel inflamation
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Infections and infestations
Cutaneous infection
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Infections and infestations
Septicemia
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Investigations
Lymphocytes decreased
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Injury, poisoning and procedural complications
Complication of vascular access
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Metabolism and nutrition disorders
Hypokaliemia
|
2.2%
1/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
General disorders
Fatigue
|
8.9%
4/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
Other adverse events
| Measure |
5Fu-mitomycine-panitumumab + Radiotherapy
n=45 participants at risk
5 FU = 400 mg days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 mg/kg days 1, weeks: 1, 3, 5, 8 and 10
radiochemotherapy: Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
55.6%
25/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Skin and subcutaneous tissue disorders
Prurit
|
26.7%
12/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
55.6%
25/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Skin and subcutaneous tissue disorders
Cutaneous rash
|
24.4%
11/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Reproductive system and breast disorders
Vulvar and vaginal inflammation
|
48.9%
22/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Renal and urinary disorders
Cystitis
|
42.2%
19/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Renal and urinary disorders
Pollakiurie
|
15.6%
7/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
75.6%
34/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
10/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Anal pain
|
42.2%
19/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Mucositis
|
33.3%
15/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
53.3%
24/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Proctitis/Rectitis
|
53.3%
24/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
12/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
30/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Injury, poisoning and procedural complications
Radiation Dermatitis
|
31.1%
14/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
64.4%
29/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
Metabolism and nutrition disorders
Hypokaliemia
|
20.0%
9/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
General disorders
Fatigue
|
77.8%
35/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
|
General disorders
Fever
|
15.6%
7/45 • Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
|
Additional Information
Karine Le Malicot
Fédération Francophone de Cancérologie Digestive
Phone: +33 3 80 39 34 79
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place