PRODIGE 85- KANALRAD : Prospective Randomized Phase III Study Evaluating Induction Chemotherapy (Modified DCF 4 Cycles) Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced Anal Squamous Cell Carcinoma (T3-4 or N1a, b or c)

Status: Recruiting
Location: See all (112) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer. the efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerability, response rate and quality of life. This trial will be offered to patients over 18 years of age with locally advanced anal cancer without metastasis (T3-4 or N1). It is open to patients over 75 years of age subject to a favorable evaluation by an oncogeriatrician. It is also open to immunocompromised patients (HIV+) if their immunity is well controlled under antiretroviral treatment.The standard chemoradiotherapy treatment consists of 33 sessions of radiation, one session per day from Monday to Friday for 6.5 weeks. It is combined with chemotherapy that includes mitomycin during the first and fifth weeks of radiation therapy, as well as capecitabine that are taken on the days of radiation therapy.In the experimental arm, this chemoradiotherapy treatment is preceded by 4 sessions of mDCF chemotherapy performed every 2 weeks.After treatment, patients are followed up at 8 weeks, then every 4 months for 2 years, and every 6 months for the last year with clinical examination and imaging (CT and MRI).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Anal Squamous cell carcinoma histologically proven

• Locally advanced tumors without metastases

‣ Stage T3 or T4

⁃ Stage N1 (a, b or c) - any T (T1 to T4)

• Age ≥18 and ≤ 75 or \> 75 in case of score G8 \> 14 or favourable oncogeriatric assessment

• Measurable tumor on MRI

• Able to receive chemotherapy and radiotherapy

• No major comorbidity that may preclude the delivery of treatment

• Adequate hematologic function: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100 000/mm3, Hb ≥ 9g/dl

• Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml/min

• Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN

⁃ WHO performance status \< 2

⁃ Signature of informed consent

⁃ A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a urine pregnancy test, it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (Recommendations related to contraception and pregnancy testing in clinical trials)

⁃ Female patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male (until 6 months after the end of the investigational treatments) and female patients of childbearing potential (until 7.5 months after the end of treatment with cisplatine)

⁃ Patient to be covered by a regimen of French Social Security system.

Locations
Other Locations
France
AGEN-Cromg
NOT_YET_RECRUITING
Agen
Clinique Calabet
NOT_YET_RECRUITING
Agen
AIX EN PROVENCE CH Pays d'Aix
NOT_YET_RECRUITING
Aix-en-provence
Amiens - Clinique de L'Europe
NOT_YET_RECRUITING
Amiens
ANTONY Hôpital Privé
NOT_YET_RECRUITING
Antony
Argenteuil - Ch
RECRUITING
Argenteuil
ARRAS Les Bonnettes
NOT_YET_RECRUITING
Arras
ARRAS Marie Curie
NOT_YET_RECRUITING
Arras
AURILLAC-Henri Mondor
NOT_YET_RECRUITING
Aurillac
Centre Medico Chirurgical
NOT_YET_RECRUITING
Aurillac
AUXERRE CH GHT Unyon
RECRUITING
Auxerre
Avignon Icap
RECRUITING
Avignon
Avranches - Hopital Prive de La Baie
RECRUITING
Avranches
Bayonne- Clinique Belharra
NOT_YET_RECRUITING
Bayonne
BEAUVAIS-Simone Veil
NOT_YET_RECRUITING
Beauvais
Besancon Chu
RECRUITING
Besançon
Beuvry - Clinique Ambroise Pare
NOT_YET_RECRUITING
Beuvry
Beuvry Pierre Curie
NOT_YET_RECRUITING
Beuvry
Bordeaux - Privé - Tivoli
RECRUITING
Bordeaux
BORDEAUX-Institut Bergonié
RECRUITING
Bordeaux
Institut Bergonié
RECRUITING
Bordeaux
Pessac - Chu -Haut Leveque
RECRUITING
Bordeaux
Ch Duchenne
NOT_YET_RECRUITING
Boulogne-sur-mer
BREST Pasteur Lanroze
RECRUITING
Brest
CAEN Polyclinique du Parc
RECRUITING
Caen
CAEN-François Baclesse
RECRUITING
Caen
Cahors -Ch
NOT_YET_RECRUITING
Cahors
Caluire Et Cuire-Infirmerie Protestante
NOT_YET_RECRUITING
Caluire-et-cuire
Chalon-Sur-Saone Hopital Sainte Marie
RECRUITING
Chalon-sur-saône
Chambery Ch
RECRUITING
Chambéry
Chambray Les Tours-Roc37
RECRUITING
Chambray-lès-tours
Centre Jean Perrin
NOT_YET_RECRUITING
Clermont-ferrand
Chu Estaing
NOT_YET_RECRUITING
Clermont-ferrand
Centre de Radiothérapie Savoie Nord
NOT_YET_RECRUITING
Contamine-sur-arve
Clinique de Flandre
NOT_YET_RECRUITING
Coudekerque-branche
CRETEIL-Henri Mondor CHU
RECRUITING
Créteil
DAX CH
NOT_YET_RECRUITING
Dax
DECHY-Léonard de Vinci
RECRUITING
Dechy
Dijon - Chu François Mitterrand
RECRUITING
Dijon
DIJON-GF Leclerc
NOT_YET_RECRUITING
Dijon
DIJON-Institut de Cancérologie de Bourgogne
RECRUITING
Dijon
Ghm Grenoble - Institut Daniel Hollard
NOT_YET_RECRUITING
Grenoble
LA ROCHE-SUR-YON CHD Vendée
RECRUITING
La Roche-sur-yon
Guillaume Le Conquérant
NOT_YET_RECRUITING
Le Havre
LE HAVRE-l'Estuaire
NOT_YET_RECRUITING
Le Havre
LE MANS-CH Victor Hugo
RECRUITING
Le Mans
Lille - Hopital Prive La Louviere
NOT_YET_RECRUITING
Lille
Limoges - Polyclinique Francois Chenieux
NOT_YET_RECRUITING
Limoges
Limoges-Chu Dupuytren
NOT_YET_RECRUITING
Limoges
LONGJUMEAU-GHNE Hôpital d'Antony
NOT_YET_RECRUITING
Longjumeau
Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff
RECRUITING
Lorient
LYON Jean Mermoz
RECRUITING
Lyon
LYON- Léon Bérard
NOT_YET_RECRUITING
Lyon
LYON-Saint Joseph
NOT_YET_RECRUITING
Lyon
MARSEILLE Institut Paoli Calmettes
RECRUITING
Marseille
MARSEILLE Saint-Joseph
RECRUITING
Marseille
MARSEILLE-Hôpital la Timone
RECRUITING
Marseille
Montbeliard Ch
NOT_YET_RECRUITING
Montbéliard
MONTPELLIER-ICM Val d'Aurelle
RECRUITING
Montpellier
Mougins Cac
RECRUITING
Mougins
MULHOUSE CH Emile Muller
RECRUITING
Mulhouse
Nantes - Hopital Prive Du Confluent
NOT_YET_RECRUITING
Nantes
NEUILLY-SUR-SEINE GH Hartmann
NOT_YET_RECRUITING
Neuilly-sur-seine
NICE-Antoine LACASSAGNE
RECRUITING
Nice
Nimes Chu
NOT_YET_RECRUITING
Nîmes
Centre Hospitalier
NOT_YET_RECRUITING
Niort
ORLEANS Centre Hospitalier Régional
NOT_YET_RECRUITING
Orléans
OSNY-CHP Sainte-Marie
RECRUITING
Osny
Paris - Ap-Hp - Hopital Tenon
NOT_YET_RECRUITING
Paris
Paris - Chu -Saint Louis Aphp
NOT_YET_RECRUITING
Paris
PARIS GHD Croix Saint-Simon
RECRUITING
Paris
PARIS Hopital Europeen Georges-Pompidou
RECRUITING
Paris
PARIS Institut Curie
RECRUITING
Paris
PARIS-Saint Joseph
RECRUITING
Paris
Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees
NOT_YET_RECRUITING
Pau
PERIGUEUX-Hôpital Francheville
RECRUITING
Périgueux
Plerin Hopital Prive Des Cotes D'Armor - Centre Cario
NOT_YET_RECRUITING
Plérin
POITIERS- CHU la Miletrie
RECRUITING
Poitiers
PRINGY-Annecy Genevois CH
NOT_YET_RECRUITING
Pringy
REIMS-CHU Robert Debré
RECRUITING
Reims
REIMS-Jean Godinot
RECRUITING
Reims
Rennes - Centre Eugene Marquis
NOT_YET_RECRUITING
Rennes
Rennes Chu Pontchaillou
NOT_YET_RECRUITING
Rennes
RODEZ CH
NOT_YET_RECRUITING
Rodez
Hopitaux Prives Rouennais - Clinique Mathilde
NOT_YET_RECRUITING
Rouen
ROUEN-Frédéric Joliot
RECRUITING
Rouen
Saint Denis Ch
NOT_YET_RECRUITING
Saint-denis
CHU
NOT_YET_RECRUITING
Saint-etienne
Saint Herblain Ico
RECRUITING
Saint-herblain
SAINT NAZAIRE CM l'Estuaire
NOT_YET_RECRUITING
Saint-nazaire
Centre Hospitalier
NOT_YET_RECRUITING
Saint-quentin
SARCELLES - Institut de Cancérologie Paris Nord
NOT_YET_RECRUITING
Sarcelles
Clinique Cote d'Emeraude
NOT_YET_RECRUITING
St-malo
Saint Malo Ch
NOT_YET_RECRUITING
St-malo
Strasbourg Icans
RECRUITING
Strasbourg
STRASBOURG Sainte Anne
RECRUITING
Strasbourg
Tarbes - Lourdes - Ch
NOT_YET_RECRUITING
Tarbes
Tarbes - Polyclinique de L'Ormeau
RECRUITING
Tarbes
Thonon Les Bains - Hopitaux Du Leman
NOT_YET_RECRUITING
Thonon-les-bains
Centre de Radiothérapie Saint-Louis
NOT_YET_RECRUITING
Toulon
TOULON-Sainte Anne
NOT_YET_RECRUITING
Toulon
Toulouse - Oncopole Institut Claudius Regaud
NOT_YET_RECRUITING
Toulouse
Toulouse Chu - Hopital Rangueil
RECRUITING
Toulouse
TOULOUSE-Clinique Pasteur
RECRUITING
Toulouse
TOURS CHU Trousseau
RECRUITING
Tours
Valence - Centre Marie Curie
NOT_YET_RECRUITING
Valence
Valence Ch
NOT_YET_RECRUITING
Valence
VALENCE Drôme-Ardèche
NOT_YET_RECRUITING
Valence
Vandoeuvre Les Nancy-Ic Lorraine
RECRUITING
Vandœuvre-lès-nancy
VILLEJUIF Gustave Roussy
RECRUITING
Villejuif
Centre de Radiothérapie Bayard
NOT_YET_RECRUITING
Villeurbanne
Villeurbanne Medipole Hopital Mutualiste Lyon
NOT_YET_RECRUITING
Villeurbanne
Contact Information
Primary
Veronique Vendrely, Md-pHD
prodige85.kanalrad@ffcd.fr
+33 380393483
Backup
Jérémie BEZ, MS
prodige85.kanalrad@ffcd.fr
+33 380393483
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 310
Treatments
Active_comparator: Control arm
Pelvic chemoradiotherapy Radiotherapy consists of conformational intensity-modulated external irradiation with simultaneous integrated boost (IMRT-SIB) with 2 level of dose (30 sessions)~* 49.5 Gy (5 x 1.65 Gy/week) to the pelvis~* 60 Gy (5 x 2 Gy /week) to the primary tumor and initially involved nodes~Concomitant Chemotherapy consists of Mitomycin-C (10 mg/m2 intravenous infusion at D1 and D29) and Capecitabine (1650 mg/m²/day divided in two oral intakes 825 mg/m² twice a day, five days a week). Patients should be counseled to only take capecitabine on the days when radiotherapy is being given
Experimental: Exeprimental arm
Induction chemotherapy with mDCF (4 cycles) followed by pelvic chemoradiotherapy~Induction chemotherapy consists of mDCF administered every 2 weeks:~* Docetaxel (40 mg/m², day 1),~* Cisplatin (40 mg/m², day 1)~* 5-FU (1200 mg/m²/day IV for 2 days) Chemoradiotherapy is the same as described above in control arm
Related Therapeutic Areas
Sponsors
Leads: Federation Francophone de Cancerologie Digestive
Collaborators: Fondation ARCAD

This content was sourced from clinicaltrials.gov

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