Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA
NCT ID: NCT06207981
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
310 participants
INTERVENTIONAL
2024-02-26
2030-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
NCT01515787
A Study of Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.
NCT01941966
Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
NCT03875781
Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
NCT02008656
Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma
NCT02402842
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Concomitant chemotherapy (Capecitabin + Mitomycin-C)
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
radiotherapy
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
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
induction chemotherapy (mDCF)
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)
Concomitant chemotherapy (Capecitabin + Mitomycin-C)
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
radiotherapy
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
induction chemotherapy (mDCF)
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)
Concomitant chemotherapy (Capecitabin + Mitomycin-C)
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
radiotherapy
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Locally advanced tumors without metastases
* Stage T3 or T4
* Stage N1 (a, b or c) - any T (T1 to T4)
3. Age ≥18 and ≤ 75 or \> 75 in case of score G8 \> 14 or favourable oncogeriatric assessment
4. Measurable tumor on MRI
5. Able to receive chemotherapy and radiotherapy
6. No major comorbidity that may preclude the delivery of treatment
7. Adequate hematologic function: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100 000/mm3, Hb ≥ 9g/dl
8. Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml/min
9. Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN
10. WHO performance status \< 2
11. Signature of informed consent
12. 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)
13. 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)
14. Patient to be covered by a regimen of French Social Security system.
Exclusion Criteria
2. Stage T1N0 or T2N0
3. History of pelvic radiotherapy
4. Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
5. Positive HIV serology with CD4 \< 400 / mm3
6. Presence of neuropathy \> grade 2 according to NCIC-CTC 4.0
7. Contraindication for chemotherapy and/or radiotherapy
8. Concomitant treatment with CYP3A4 inhibitors or inducers
9. Symptomatic cardiac or coronary insufficiency
10. Progressive active infection or any unbalanced progressive severe condition in the last 6 months
11. No contraindication to MRI imaging
12. Other cancer treated within the last 3 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma or any other carcinoma in situ considered as cured
13. breastfeeding woman.
14. Persons deprived of liberty or under guardianship or incapable of giving consent
15. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
16. Live attenuated vaccines within 4 weeks before randomization 17. In case of hearing problem 18. In case of combination with phenytoin with prophylactic aim 19. In case of recent or concomitant treatment brivudine
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation ARCAD
OTHER
Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Veronique Vendrely, Md-pHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AGEN-Cromg
Agen, , France
Clinique Calabet
Agen, , France
AIX EN PROVENCE CH Pays d'Aix
Aix-en-Provence, , France
Amiens - Clinique de L'Europe
Amiens, , France
ANTONY Hôpital Privé
Antony, , France
Argenteuil - Ch
Argenteuil, , France
ARRAS Les Bonnettes
Arras, , France
ARRAS Marie Curie
Arras, , France
AURILLAC-Henri Mondor
Aurillac, , France
Centre Medico Chirurgical
Aurillac, , France
AUXERRE CH GHT Unyon
Auxerre, , France
Avignon Icap
Avignon, , France
Avranches - Hopital Prive de La Baie
Avranches, , France
Bayonne- Clinique Belharra
Bayonne, , France
BEAUVAIS-Simone Veil
Beauvais, , France
Besancon Chu
Besançon, , France
Beuvry - Clinique Ambroise Pare
Beuvry, , France
Beuvry Pierre Curie
Beuvry, , France
Bordeaux - Privé - Tivoli
Bordeaux, , France
BORDEAUX-Institut Bergonié
Bordeaux, , France
Institut Bergonié
Bordeaux, , France
Pessac - Chu -Haut Leveque
Bordeaux, , France
Ch Duchenne
Boulogne-sur-Mer, , France
BREST Pasteur Lanroze
Brest, , France
CAEN Polyclinique du Parc
Caen, , France
CAEN-François Baclesse
Caen, , France
Cahors -Ch
Cahors, , France
Caluire Et Cuire-Infirmerie Protestante
Caluire-et-Cuire, , France
Chalon-Sur-Saone Hopital Sainte Marie
Chalon-sur-Saône, , France
Chambery Ch
Chambéry, , France
Chambray Les Tours-Roc37
Chambray-lès-Tours, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Chu Estaing
Clermont-Ferrand, , France
Centre de Radiothérapie Savoie Nord
Contamine-sur-Arve, , France
Clinique de Flandre
Coudekerque-Branche, , France
CRETEIL-Henri Mondor CHU
Créteil, , France
DAX CH
Dax, , France
DECHY-Léonard de Vinci
Dechy, , France
Dijon - Chu François Mitterrand
Dijon, , France
DIJON-GF Leclerc
Dijon, , France
DIJON-Institut de Cancérologie de Bourgogne
Dijon, , France
Ghm Grenoble - Institut Daniel Hollard
Grenoble, , France
LA ROCHE-SUR-YON CHD Vendée
La Roche-sur-Yon, , France
Guillaume Le Conquérant
Le Havre, , France
LE HAVRE-l'Estuaire
Le Havre, , France
LE MANS-CH Victor Hugo
Le Mans, , France
Lille - Hopital Prive La Louviere
Lille, , France
Limoges - Polyclinique Francois Chenieux
Limoges, , France
Limoges-Chu Dupuytren
Limoges, , France
LONGJUMEAU-GHNE Hôpital d'Antony
Longjumeau, , France
Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff
Lorient, , France
LYON Jean Mermoz
Lyon, , France
LYON- Léon Bérard
Lyon, , France
LYON-Saint Joseph
Lyon, , France
MARSEILLE Institut Paoli Calmettes
Marseille, , France
MARSEILLE Saint-Joseph
Marseille, , France
MARSEILLE-Hôpital la Timone
Marseille, , France
Montbeliard Ch
Montbéliard, , France
MONTPELLIER-ICM Val d'Aurelle
Montpellier, , France
Mougins Cac
Mougins, , France
MULHOUSE CH Emile Muller
Mulhouse, , France
Nantes - Hopital Prive Du Confluent
Nantes, , France
NEUILLY-SUR-SEINE GH Hartmann
Neuilly-sur-Seine, , France
NICE-Antoine LACASSAGNE
Nice, , France
Centre Hospitalier
Niort, , France
Nimes Chu
Nîmes, , France
ORLEANS Centre Hospitalier Régional
Orléans, , France
OSNY-CHP Sainte-Marie
Osny, , France
Paris - Ap-Hp - Hopital Tenon
Paris, , France
Paris - Chu -Saint Louis Aphp
Paris, , France
PARIS GHD Croix Saint-Simon
Paris, , France
PARIS Hopital Europeen Georges-Pompidou
Paris, , France
PARIS Institut Curie
Paris, , France
PARIS-Saint Joseph
Paris, , France
Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees
Pau, , France
PERIGUEUX-Hôpital Francheville
Périgueux, , France
Plerin Hopital Prive Des Cotes D'Armor - Centre Cario
Plérin, , France
POITIERS- CHU la Miletrie
Poitiers, , France
PRINGY-Annecy Genevois CH
Pringy, , France
REIMS-CHU Robert Debré
Reims, , France
REIMS-Jean Godinot
Reims, , France
Rennes - Centre Eugene Marquis
Rennes, , France
Rennes Chu Pontchaillou
Rennes, , France
RODEZ CH
Rodez, , France
Hopitaux Prives Rouennais - Clinique Mathilde
Rouen, , France
ROUEN-Frédéric Joliot
Rouen, , France
Saint Denis Ch
Saint-Denis, , France
CHU
Saint-Etienne, , France
Saint Herblain Ico
Saint-Herblain, , France
SAINT NAZAIRE CM l'Estuaire
Saint-Nazaire, , France
Centre Hospitalier
Saint-Quentin, , France
SARCELLES - Institut de Cancérologie Paris Nord
Sarcelles, , France
Clinique Cote d'Emeraude
St-Malo, , France
Saint Malo Ch
St-Malo, , France
Strasbourg Icans
Strasbourg, , France
STRASBOURG Sainte Anne
Strasbourg, , France
Tarbes - Lourdes - Ch
Tarbes, , France
Tarbes - Polyclinique de L'Ormeau
Tarbes, , France
Thonon Les Bains - Hopitaux Du Leman
Thonon-les-Bains, , France
Centre de Radiothérapie Saint-Louis
Toulon, , France
TOULON-Sainte Anne
Toulon, , France
Toulouse - Oncopole Institut Claudius Regaud
Toulouse, , France
Toulouse Chu - Hopital Rangueil
Toulouse, , France
TOULOUSE-Clinique Pasteur
Toulouse, , France
TOURS CHU Trousseau
Tours, , France
Valence - Centre Marie Curie
Valence, , France
Valence Ch
Valence, , France
VALENCE Drôme-Ardèche
Valence, , France
Vandoeuvre Les Nancy-Ic Lorraine
Vandœuvre-lès-Nancy, , France
VILLEJUIF Gustave Roussy
Villejuif, , France
Centre de Radiothérapie Bayard
Villeurbanne, , France
Villeurbanne Medipole Hopital Mutualiste Lyon
Villeurbanne, , France
Reunion - Chu Sud
Saint-Pierre, , Reunion
La Reunion - Clinique Prive Sainte Clotilde
Sainte-Clotilde, , Reunion
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Olivier BERNARD
Role: primary
Madeleine Pasquie
Role: primary
Juliette MOREAU
Role: primary
Claire TRICAUD
Role: primary
Jean-Philippe WAGNER
Role: primary
Fabrice Ramiandrisoa
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Prodige 85 KANALRAD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.