New hope for advanced anal cancer: chemo before radiation may boost survival

NCT ID NCT06207981

Disease control Sponsor: Federation Francophone de Cancerologie Digestive Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests whether giving a specific chemotherapy combination (mDCF) before standard chemoradiotherapy can improve outcomes for people with locally advanced anal cancer. About 310 adults with stage T3-4 or N1 anal cancer will be randomly assigned to either standard treatment or the experimental sequence. The main goal is to see if the new approach delays disease progression or death at two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: docetaxel, cisplatin, 5-FU (induction chemotherapy) followed by capecitabine and mitomycin-C with radiotherapy
What this could lead to: If it works, this could offer a more effective treatment for advanced anal cancer, potentially reducing the chance of relapse and improving survival.
What could go wrong: This is a phase 3 trial, but the added chemotherapy may cause more side effects. It is not yet proven to be better than the current standard, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Anal Squamous cell carcinoma histologically proven 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: 1. Presence of metastases 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

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Conditions

The condition(s) this trial relates to.

anal carcinoma anal squamous cell carcinoma anus neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

114 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AGEN-Cromg
NOT_YET_RECRUITING

Agen, France
AIX EN PROVENCE CH Pays d'Aix
NOT_YET_RECRUITING

Aix-en-Provence, France
ANTONY Hôpital Privé
NOT_YET_RECRUITING

Antony, France
ARRAS Les Bonnettes
NOT_YET_RECRUITING

Arras, France
ARRAS Marie Curie
NOT_YET_RECRUITING

Arras, France
AURILLAC-Henri Mondor
NOT_YET_RECRUITING

Aurillac, France
AUXERRE CH GHT Unyon
RECRUITING

Auxerre, France
Amiens - Clinique de L'Europe
NOT_YET_RECRUITING

Amiens, France
Argenteuil - Ch
RECRUITING

Argenteuil, France
Avignon Icap
RECRUITING

Avignon, France
Avranches - Hopital Prive de La Baie
RECRUITING

Avranches, France
BEAUVAIS-Simone Veil
NOT_YET_RECRUITING

Beauvais, France
BORDEAUX-Institut Bergonié
RECRUITING

Bordeaux, France
BREST Pasteur Lanroze
RECRUITING

Brest, France
Bayonne- Clinique Belharra
NOT_YET_RECRUITING

Bayonne, France
Besancon Chu
RECRUITING

Besançon, France
Beuvry - Clinique Ambroise Pare
NOT_YET_RECRUITING

Beuvry, France
Beuvry Pierre Curie
NOT_YET_RECRUITING

Beuvry, France
Bordeaux - Privé - Tivoli
RECRUITING

Bordeaux, France
CAEN Polyclinique du Parc
RECRUITING

Caen, France
CAEN-François Baclesse
RECRUITING

Caen, France
CHU
NOT_YET_RECRUITING

Saint-Etienne, France
CRETEIL-Henri Mondor CHU
RECRUITING

Créteil, France
Cahors -Ch
NOT_YET_RECRUITING

Cahors, France
Caluire Et Cuire-Infirmerie Protestante
NOT_YET_RECRUITING

Caluire-et-Cuire, France
Centre Hospitalier
NOT_YET_RECRUITING

Niort, France
Centre Hospitalier
NOT_YET_RECRUITING

Saint-Quentin, France
Centre Jean Perrin
NOT_YET_RECRUITING

Clermont-Ferrand, France
Centre Medico Chirurgical
NOT_YET_RECRUITING

Aurillac, France
Centre de Radiothérapie Bayard
NOT_YET_RECRUITING

Villeurbanne, France
Centre de Radiothérapie Saint-Louis
NOT_YET_RECRUITING

Toulon, France
Centre de Radiothérapie Savoie Nord
NOT_YET_RECRUITING

Contamine-sur-Arve, France
Ch Duchenne
NOT_YET_RECRUITING

Boulogne-sur-Mer, France
Chalon-Sur-Saone Hopital Sainte Marie
RECRUITING

Chalon-sur-Saône, France
Chambery Ch
RECRUITING

Chambéry, France
Chambray Les Tours-Roc37
RECRUITING

Chambray-lès-Tours, France
Chu Estaing
NOT_YET_RECRUITING

Clermont-Ferrand, France
Clinique Calabet
NOT_YET_RECRUITING

Agen, France
Clinique Cote d'Emeraude
NOT_YET_RECRUITING

St-Malo, France
Clinique de Flandre
NOT_YET_RECRUITING

Coudekerque-Branche, France
DAX CH
NOT_YET_RECRUITING

Dax, France
DECHY-Léonard de Vinci
RECRUITING

Dechy, France
DIJON-GF Leclerc
NOT_YET_RECRUITING

Dijon, France
DIJON-Institut de Cancérologie de Bourgogne
RECRUITING

Dijon, France
Dijon - Chu François Mitterrand
RECRUITING

Dijon, France
Ghm Grenoble - Institut Daniel Hollard
NOT_YET_RECRUITING

Grenoble, France
Guillaume Le Conquérant
NOT_YET_RECRUITING

Le Havre, France
Hopitaux Prives Rouennais - Clinique Mathilde
NOT_YET_RECRUITING

Rouen, France
Institut Bergonié
RECRUITING

Bordeaux, France
LA ROCHE-SUR-YON CHD Vendée
RECRUITING

La Roche-sur-Yon, France
LE HAVRE-l'Estuaire
NOT_YET_RECRUITING

Le Havre, France
LE MANS-CH Victor Hugo
RECRUITING

Le Mans, France
LONGJUMEAU-GHNE Hôpital d'Antony
NOT_YET_RECRUITING

Longjumeau, France
LYON Jean Mermoz
RECRUITING

Lyon, France
LYON- Léon Bérard
NOT_YET_RECRUITING

Lyon, France
LYON-Saint Joseph
NOT_YET_RECRUITING

Lyon, France
La Reunion - Clinique Prive Sainte Clotilde
NOT_YET_RECRUITING

Sainte-Clotilde, Reunion
Lille - Hopital Prive La Louviere
NOT_YET_RECRUITING

Lille, France
Limoges - Polyclinique Francois Chenieux
NOT_YET_RECRUITING

Limoges, France
Limoges-Chu Dupuytren
NOT_YET_RECRUITING

Limoges, France
Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff
RECRUITING

Lorient, France
MARSEILLE Institut Paoli Calmettes
RECRUITING

Marseille, France
MARSEILLE Saint-Joseph
RECRUITING

Marseille, France
MARSEILLE-Hôpital la Timone
RECRUITING

Marseille, France
MONTPELLIER-ICM Val d'Aurelle
RECRUITING

Montpellier, France
MULHOUSE CH Emile Muller
RECRUITING

Mulhouse, France
Montbeliard Ch
NOT_YET_RECRUITING

Montbéliard, France
Mougins Cac
RECRUITING

Mougins, France
NEUILLY-SUR-SEINE GH Hartmann
NOT_YET_RECRUITING

Neuilly-sur-Seine, France
NICE-Antoine LACASSAGNE
RECRUITING

Nice, France
Nantes - Hopital Prive Du Confluent
NOT_YET_RECRUITING

Nantes, France
Nimes Chu
NOT_YET_RECRUITING

Nîmes, France
ORLEANS Centre Hospitalier Régional
NOT_YET_RECRUITING

Orléans, France
OSNY-CHP Sainte-Marie
RECRUITING

Osny, France
PARIS GHD Croix Saint-Simon
RECRUITING

Paris, France
PARIS Hopital Europeen Georges-Pompidou
RECRUITING

Paris, France
PARIS Institut Curie
RECRUITING

Paris, France
PARIS-Saint Joseph
RECRUITING

Paris, France
PERIGUEUX-Hôpital Francheville
RECRUITING

Périgueux, France
POITIERS- CHU la Miletrie
RECRUITING

Poitiers, France
PRINGY-Annecy Genevois CH
NOT_YET_RECRUITING

Pringy, France
Paris - Ap-Hp - Hopital Tenon
NOT_YET_RECRUITING

Paris, France
Paris - Chu -Saint Louis Aphp
NOT_YET_RECRUITING

Paris, France
Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees
NOT_YET_RECRUITING

Pau, France
Pessac - Chu -Haut Leveque
RECRUITING

Bordeaux, France
Plerin Hopital Prive Des Cotes D'Armor - Centre Cario
NOT_YET_RECRUITING

Plérin, France
REIMS-CHU Robert Debré
RECRUITING

Reims, France
REIMS-Jean Godinot
RECRUITING

Reims, France
RODEZ CH
NOT_YET_RECRUITING

Rodez, France
ROUEN-Frédéric Joliot
RECRUITING

Rouen, France
Rennes - Centre Eugene Marquis
NOT_YET_RECRUITING

Rennes, France
Rennes Chu Pontchaillou
NOT_YET_RECRUITING

Rennes, France
Reunion - Chu Sud
NOT_YET_RECRUITING

Saint-Pierre, Reunion
SAINT NAZAIRE CM l'Estuaire
NOT_YET_RECRUITING

Saint-Nazaire, France
SARCELLES - Institut de Cancérologie Paris Nord
NOT_YET_RECRUITING

Sarcelles, France
STRASBOURG Sainte Anne
RECRUITING

Strasbourg, France
Saint Denis Ch
NOT_YET_RECRUITING

Saint-Denis, France
Saint Herblain Ico
RECRUITING

Saint-Herblain, France
Saint Malo Ch
NOT_YET_RECRUITING

St-Malo, France
Strasbourg Icans
RECRUITING

Strasbourg, France
TOULON-Sainte Anne
NOT_YET_RECRUITING

Toulon, France
TOULOUSE-Clinique Pasteur
RECRUITING

Toulouse, France
TOURS CHU Trousseau
RECRUITING

Tours, France
Tarbes - Lourdes - Ch
NOT_YET_RECRUITING

Tarbes, France
Tarbes - Polyclinique de L'Ormeau
RECRUITING

Tarbes, France
Thonon Les Bains - Hopitaux Du Leman
NOT_YET_RECRUITING

Thonon-les-Bains, France
Toulouse - Oncopole Institut Claudius Regaud
NOT_YET_RECRUITING

Toulouse, France
Toulouse Chu - Hopital Rangueil
RECRUITING

Toulouse, France
VALENCE Drôme-Ardèche
NOT_YET_RECRUITING

Valence, France
VILLEJUIF Gustave Roussy
RECRUITING

Villejuif, France
Valence - Centre Marie Curie
NOT_YET_RECRUITING

Valence, France
Valence Ch
NOT_YET_RECRUITING

Valence, France
Vandoeuvre Les Nancy-Ic Lorraine
RECRUITING

Vandœuvre-lès-Nancy, France
Villeurbanne Medipole Hopital Mutualiste Lyon
NOT_YET_RECRUITING

Villeurbanne, France

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