Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA (KANALRAD)

August 29, 2025 updated by: Federation Francophone de Cancerologie Digestive

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Agen, France
        • Not yet recruiting
        • AGEN-Cromg
        • Contact:
      • Agen, France
        • Not yet recruiting
        • Clinique Calabet
        • Contact:
          • Olivier BERNARD
      • Aix-en-Provence, France
        • Not yet recruiting
        • AIX EN PROVENCE CH Pays d'Aix
        • Contact:
      • Amiens, France
        • Not yet recruiting
        • Amiens - Clinique de l'Europe
        • Contact:
      • Antony, France
        • Not yet recruiting
        • ANTONY Hôpital Privé
        • Contact:
      • Argenteuil, France
      • Arras, France
        • Not yet recruiting
        • ARRAS Les Bonnettes
        • Contact:
      • Arras, France
        • Not yet recruiting
        • ARRAS Marie Curie
        • Contact:
      • Aurillac, France
        • Not yet recruiting
        • AURILLAC-Henri Mondor
        • Contact:
      • Aurillac, France
        • Not yet recruiting
        • Centre Medico Chirurgical
        • Contact:
          • Madeleine Pasquie
      • Auxerre, France
        • Recruiting
        • AUXERRE CH GHT Unyon
        • Contact:
      • Avignon, France
        • Recruiting
        • Avignon Icap
        • Contact:
      • Avranches, France
        • Recruiting
        • Avranches - Hopital Prive de La Baie
        • Contact:
      • Bayonne, France
        • Not yet recruiting
        • Bayonne- Clinique Belharra
        • Contact:
      • Beauvais, France
      • Besançon, France
      • Beuvry, France
        • Not yet recruiting
        • Beuvry - Clinique Ambroise Pare
        • Contact:
      • Beuvry, France
      • Bordeaux, France
      • Bordeaux, France
      • Bordeaux, France
        • Recruiting
        • Bordeaux - Privé - Tivoli
        • Contact:
      • Bordeaux, France
      • Boulogne-sur-Mer, France
      • Brest, France
      • Caen, France
      • Caen, France
      • Cahors, France
      • Caluire-et-Cuire, France
      • Chalon-sur-Saône, France
        • Recruiting
        • Chalon-Sur-Saone Hopital Sainte Marie
        • Contact:
      • Chambray-lès-Tours, France
        • Recruiting
        • Chambray Les Tours-Roc37
        • Contact:
      • Chambéry, France
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Centre Jean Perrin
        • Contact:
          • Juliette MOREAU
      • Clermont-Ferrand, France
      • Contamine-sur-Arve, France
        • Not yet recruiting
        • Centre de Radiothérapie Savoie Nord
        • Contact:
          • Claire TRICAUD
      • Coudekerque-Branche, France
        • Not yet recruiting
        • Clinique de Flandre
        • Contact:
          • Jean-Philippe WAGNER
      • Créteil, France
      • Dax, France
        • Not yet recruiting
        • DAX CH
        • Contact:
      • Dechy, France
        • Recruiting
        • DECHY-Léonard de Vinci
        • Contact:
      • Dijon, France
        • Recruiting
        • Dijon - Chu François Mitterrand
        • Contact:
      • Dijon, France
        • Not yet recruiting
        • DIJON-GF Leclerc
        • Contact:
      • Dijon, France
        • Recruiting
        • DIJON-Institut de Cancérologie de Bourgogne
        • Contact:
      • Grenoble, France
        • Not yet recruiting
        • Ghm Grenoble - Institut Daniel Hollard
        • Contact:
      • La Roche-sur-Yon, France
      • Le Havre, France
        • Not yet recruiting
        • Guillaume Le Conquérant
        • Contact:
      • Le Havre, France
        • Not yet recruiting
        • LE HAVRE-l'Estuaire
        • Contact:
      • Le Mans, France
        • Recruiting
        • LE MANS-CH Victor Hugo
        • Contact:
      • Lille, France
        • Not yet recruiting
        • Lille - Hopital Prive La Louviere
        • Contact:
      • Limoges, France
        • Not yet recruiting
        • Limoges - Polyclinique Francois Chenieux
        • Contact:
      • Limoges, France
      • Longjumeau, France
        • Not yet recruiting
        • LONGJUMEAU-GHNE Hôpital d'Antony
        • Contact:
      • Lorient, France
        • Recruiting
        • Lorient - Groupe Hospitalier Bretagne Sud - Site Du Scorff
        • Contact:
      • Lyon, France
      • Lyon, France
      • Lyon, France
      • Marseille, France
        • Recruiting
        • MARSEILLE Institut Paoli Calmettes
        • Contact:
      • Marseille, France
      • Marseille, France
        • Recruiting
        • MARSEILLE-Hôpital la Timone
        • Contact:
      • Montbéliard, France
      • Montpellier, France
      • Mougins, France
        • Recruiting
        • Mougins Cac
        • Contact:
      • Mulhouse, France
        • Recruiting
        • MULHOUSE CH Emile Muller
        • Contact:
      • Nantes, France
      • Neuilly-sur-Seine, France
        • Not yet recruiting
        • NEUILLY-SUR-SEINE GH Hartmann
        • Contact:
      • Nice, France
      • Niort, France
      • Nîmes, France
      • Orléans, France
        • Not yet recruiting
        • ORLEANS Centre Hospitalier Régional
        • Contact:
      • Osny, France
        • Recruiting
        • OSNY-CHP Sainte-Marie
        • Contact:
      • Paris, France
        • Not yet recruiting
        • Paris - Ap-Hp - Hopital Tenon
        • Contact:
      • Paris, France
        • Not yet recruiting
        • Paris - Chu -Saint Louis Aphp
        • Contact:
      • Paris, France
      • Paris, France
        • Recruiting
        • PARIS Hopital Europeen Georges-Pompidou
        • Contact:
      • Paris, France
        • Recruiting
        • PARIS Institut Curie
        • Contact:
      • Paris, France
        • Recruiting
        • PARIS-Saint Joseph
        • Contact:
      • Pau, France
        • Not yet recruiting
        • Pau Groupe de Radiotherapie Et D'Oncologie Des Pyrenees
        • Contact:
      • Plérin, France
        • Not yet recruiting
        • Plerin Hopital Prive Des Cotes D'Armor - Centre Cario
        • Contact:
      • Poitiers, France
      • Pringy, France
      • Périgueux, France
        • Recruiting
        • PERIGUEUX-Hôpital Francheville
        • Contact:
      • Reims, France
        • Recruiting
        • REIMS-CHU Robert Debré
        • Contact:
      • Reims, France
      • Rennes, France
        • Not yet recruiting
        • Rennes - Centre Eugene Marquis
        • Contact:
      • Rennes, France
      • Rodez, France
        • Not yet recruiting
        • RODEZ CH
        • Contact:
      • Rouen, France
        • Not yet recruiting
        • Hopitaux Prives Rouennais - Clinique Mathilde
        • Contact:
      • Rouen, France
      • Saint-Denis, France
      • Saint-Etienne, France
      • Saint-Herblain, France
      • Saint-Nazaire, France
      • Saint-Quentin, France
      • Sarcelles, France
        • Not yet recruiting
        • SARCELLES - Institut de Cancérologie Paris Nord
        • Contact:
      • St-Malo, France
        • Not yet recruiting
        • Clinique Cote d'Emeraude
        • Contact:
          • Fabrice Ramiandrisoa
      • St-Malo, France
        • Not yet recruiting
        • Saint Malo Ch
        • Contact:
      • Strasbourg, France
      • Strasbourg, France
        • Recruiting
        • STRASBOURG Sainte Anne
        • Contact:
      • Tarbes, France
        • Not yet recruiting
        • Tarbes - Lourdes - Ch
        • Contact:
      • Tarbes, France
        • Recruiting
        • Tarbes - Polyclinique de L'Ormeau
        • Contact:
      • Thonon-les-Bains, France
      • Toulon, France
        • Not yet recruiting
        • Centre de radiothérapie Saint-Louis
        • Contact:
      • Toulon, France
      • Toulouse, France
        • Not yet recruiting
        • Toulouse - Oncopole Institut Claudius Regaud
        • Contact:
      • Toulouse, France
        • Recruiting
        • Toulouse Chu - Hopital Rangueil
        • Contact:
      • Toulouse, France
      • Tours, France
        • Recruiting
        • TOURS CHU Trousseau
        • Contact:
      • Valence, France
        • Not yet recruiting
        • Valence - Centre Marie Curie
        • Contact:
      • Valence, France
      • Valence, France
        • Not yet recruiting
        • VALENCE Drôme-Ardèche
        • Contact:
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Vandoeuvre Les Nancy-Ic Lorraine
        • Contact:
      • Villejuif, France
      • Villeurbanne, France
        • Not yet recruiting
        • Centre de radiothérapie Bayard
        • Contact:
      • Villeurbanne, France
        • Not yet recruiting
        • Villeurbanne Medipole Hopital Mutualiste Lyon
        • Contact:
  • Reunion
      • Saint-Pierre, Reunion
      • Sainte-Clotilde, Reunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: 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
Radiation: 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
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
Drug: 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
Radiation: 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
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-related event free survival (DREFS) at 2 years
Time Frame: 2 years after last patient completed treatment
DREFS will be compared between the two arms . An event is defined as :progression, residual tumor at 6 months requiring APR, recurrence (local or metastatic) or death
2 years after last patient completed treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Collaborators

Fondation ARCAD

Investigators

  • Principal Investigator: Veronique Vendrely, Md-pHD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prodige 85 KANALRAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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