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Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.
The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).
Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).
It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.
Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5Fu-mitomycine-panitumumab + radiotherapy | Experimental | 5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, 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 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiochemotherapy | Drug | Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m² |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Response to Treatment | 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:
| 8 weeks evaluations after the end of the treatment by radiochemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Response to Treatment | 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 according to the investigator's opinion | 16 weeks after the end of the treatement by radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Véronique VENDRELY, MD | Hôpital Haut-Lévêque - Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pessac - Hôpital Haut Lévêque | Bordeaux | France | ||||
| CH - Hopitaux civils de Colmar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31185328 | Result | Vendrely V, Lemanski C, Gnep K, Barbier E, Hajbi FE, Lledo G, Dahan L, Terrebonne E, Manfredi S, Mirabel X, Mammar V, Cowen D, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase I dose-escalation study with panitumumab (FFCD 0904). Radiother Oncol. 2019 Nov;140:84-89. doi: 10.1016/j.radonc.2019.05.018. Epub 2019 Jun 8. | |
| 37315583 |
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Between January 2016 and November 2017 (Phase II), 45 patients were enrolled by 15 french centers
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 11, 2017 | Dec 22, 2022 |
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| Panitumumab | Drug | 3 or 6 mg/kg (according to dose level) |
|
| 3 Years Colostomy-free Survival (CFS) | It 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. | At 3 years after inclusion |
| Recurrence-free Survival (RFS) at 3 Years | It 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. | At 3 years after inclusion |
| Overall Survival (OS) at 12 Months | The 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. | At 12 months after inclusion |
| Colmar |
| France |
| Centre d'oncologie et de radiothérapie du Parc | Dijon | France |
| Centre Oscar Lambret | Lille | France |
| CH - CHBS - Hôpital du Scorff | Lorient | France |
| Centre Léon Bérard | Lyon | France |
| Institut Régional du Cancer Montpellier | Montpellier | France |
| Clinique Privée - Plein Ciel | Mougins | France |
| Institut Curie | Paris | France |
| Cario - HPCA - Hôpital privé des Côtes D'Armor | Plérin | France |
| CH - Annecy Genevois | Pringy | France |
| Centre Eugène Marquis | Rennes | France |
| Institut Curie | Saint-Cloud | France |
| CHU | Saint-Priest-en-Jarez | France |
| CAC - Paul Strauss | Strasbourg | France |
| Derived |
| Vendrely V, Ronchin P, Minsat M, Le Malicot K, Lemanski C, Mirabel X, Etienne PL, Lievre A, Darut-Jouve A, de la Fouchardiere C, Giraud N, Breysacher G, Argo-Leignel D, Thimonnier E, Magne N, Abdelghani MB, Lepage C, Aparicio T; for FFCD investigators/Collaborators. Panitumumab in combination with chemoradiotherapy for the treatment of locally-advanced anal canal carcinoma: Results of the FFCD 0904 phase II trial. Radiother Oncol. 2023 Sep;186:109742. doi: 10.1016/j.radonc.2023.109742. Epub 2023 Jun 12. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Complete Response to Treatment | 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:
| Posted | Count of Participants | Participants | 8 weeks evaluations after the end of the treatment by radiochemotherapy |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Complete Response to Treatment | 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 according to the investigator's opinion | Posted | Count of Participants | Participants | 16 weeks after the end of the treatement by radiotherapy |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 3 Years Colostomy-free Survival (CFS) | It 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. | Posted | Number | 95% Confidence Interval | % of patients Colostomy-free at 3 years | At 3 years after inclusion |
|
| |||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Survival (RFS) at 3 Years | It 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. | Posted | Number | 95% Confidence Interval | % of pts with Reccurence-free at 3 yrs | At 3 years after inclusion |
|
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at 12 Months | The 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. | Posted | Number | 95% Confidence Interval | % of patients alive at 12 months | At 12 months after inclusion |
|
|
Deaths were assessed up to 3 years after start of treatment Adverse Events were assessed up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 10 | 45 | 14 | 45 | 45 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal fistula | Reproductive system and breast disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Small bowel inflamation | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Small bowel obstruction | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Cutaneous infection | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Septicemia | Infections and infestations | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Lymphocytes decreased | Investigations | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Complication of vascular access | Injury, poisoning and procedural complications | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Hypokaliemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Prurit | Skin and subcutaneous tissue disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Acneiform rash | Skin and subcutaneous tissue disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Cutaneous rash | Skin and subcutaneous tissue disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Vulvar and vaginal inflammation | Reproductive system and breast disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Pollakiurie | Renal and urinary disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Proctitis/Rectitis | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Radiation Dermatitis | Injury, poisoning and procedural complications | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Hypokaliemia | Metabolism and nutrition disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
| |
| Fever | General disorders | NCI-CTC version 4.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karine Le Malicot | Fédération Francophone de Cancérologie Digestive | +33 3 80 39 34 79 | karine.le-malicot@u-bourgogne.fr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2018 | Dec 22, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Progression |
|
| Death before the evaluation |
|
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|