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Trial record 26 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Penile Diseases"

Evaluation of Lymphadenectomy and Chemotherapy TIP on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis (AFU-GETUG 25) (MEGACEP)

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ClinicalTrials.gov Identifier: NCT02817958
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

Squamous cell carcinoma of the penis is a rare tumor in Europe, whose prognosis and survival are influenced by metastatic lymph node involvement. Its frequency in France is estimated at less than 1% of human cancers. This spread follows a sequential process via the superficial and deep inguinal lymph nodes and then to the pelvic lymph nodes before metastatic dissemination.

The management of inguinal areas is the cornerstone of penile cancer. It is curative in about 80% of patients with 1 or 2 inguinal metastases. 5-years overall survival was on average 85% for pN0 patients and 40% for pN + patients. For pN + patients, 5-years overall survival was 70 to 80% for pN1 (only 1 lymph node invasion), and 30 to 40% for pN2 and 0 to 10% for pN3.

The risk of local recurrence is 5-10% for pN0 and 20-30% for pN + after local treatment by lymphadenectomy alone without chemotherapy. The average time to recurrence was 10 months. Disease-free survival at 5 years is 75-85% for pN0 and 30-45% for pN +. Its indication depends on clinical examination (presence or absence of lymph nodes palpated) and the risk of nodal disease (≥ pT1bG2).

Currently, a fine needle biopsy is the best clinical diagnosis method because it is a simple, low risk and possible in consultation. When the result is positive, it allows an early dissection. Single or double fine needle biopsy will be used in cN + patients. For patients at risk of lymp nodes involvement (cN0 and ≥ pT1B or G2), the sentinel node diagnosis may be followed by modified or bilateral lymphadenectomy.

Although lymphadenectomy alone has a curator action, it sometimes remains insufficient in patients with metastatic lymph node involvement. Therefore it seems important to develop a multimodal approach in the management of these patients in order to increase the response rate to treatment and survival.

From a Phase II trial conducted on 30 patients, the combination TIP (paclitaxel, ifosfamide and cisplatin) appears to have an efficacy / toxicity acceptable.

The TIP protocol has therefore been chosen for this trial as adjuvant or neo-adjuvant treatment in patients with high risk of lymph nodes involvement (cN0 and ≥ pT1B or G2), and with inguinal mobile palpated lymph nodes (cN +) respectively, after lymph nodes involvement proven (pN +).


Condition or disease Intervention/treatment Phase
Penile Cancer Squamous Carcinoma Drug: Chemotherapie TIP Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Study Evaluating a Multimodal Care of Inguinal Node Metastasis in Squamous Cell Carcinoma of the Penis by Bilateral Lymphadenectomy and Chemotherapy TIP
Study Start Date : April 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A-Adjuvant Chemotherapie TIP
Lymphadenectomy (+/- sentinel node) + adjuvant chemotherapie TIP modified bilateral lymphadenectomy 4 cycles every 21 days
Drug: Chemotherapie TIP
Paclitaxel, ifosfamide and cisplatine

Experimental: B-Neoadjuvant Chemotherapie TIP
fine needle biopsy or sentinel node + neoadjuvant chemotherapie TIP followed by a lymphadenectomy modified bilateral lymphadenectomy 4 cycles every 21 days
Drug: Chemotherapie TIP
Paclitaxel, ifosfamide and cisplatine




Primary Outcome Measures :
  1. survival without locoregional lymph node recurrence [ Time Frame: 24 months ]
    checked by inguinal ultrasound


Secondary Outcome Measures :
  1. Complete response rate for patients in neoadjuvant chemotherapy [ Time Frame: 6 months ]
    lack of residual tumor post surgical histopathology

  2. Survival without locoregional lymph node recurrence [ Time Frame: 3 years ]
    time between inclusion and locoregional recurrence or last evaluation

  3. Survival without metastasis [ Time Frame: 3 years ]
    time between inclusion and the date of occurrence of metastases

  4. Specific survival [ Time Frame: 3 years ]
    time between inclusion and date of death from penile cancer or treatment-related complication

  5. Overall survival [ Time Frame: 3 years ]
    time between inclusion and the death regardless of cause

  6. Toxicity [ Time Frame: 3 years ]
    CTCAE (Common Terminology Criteria for Adverse Events), v4.03

  7. Quality of life [ Time Frame: 1 year ]
    questionnaire EORTC QLQ-C30 v3



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. penile tumor histologically proven whatever the initial treatment of penile tumor: amputation or conservative surgery or brachytherapy,
  2. Mobile palpated lymph nodes (stage cN1 and cN2) whatever the T stage, Or If no palpated lymph nodes (cN0), patients with nodes involvement risk ≥pT1b and / or Grade 2
  3. Metastatic lymph node involvement
  4. Patients M0 or Mx,
  5. Age≥18 ans,
  6. ECOG 0-1,
  7. Leucocytes ≥ 1.5 G/L,
  8. Hemoglobin ≥ 9 g/dL,
  9. Platelets ≥100 000/mm3,
  10. Normal calcemia and kaliemia,
  11. AST and ALT ≤ 1.5 LNS ; total bilirubin ≤ 1.5 LNS (3 LNS in case of Gilbert disease); PAL < 2 LNS,
  12. Creatinine clearance ≥ 60 mL/mn (MDRD method),
  13. FEVG > 50%,
  14. Patients having received, read the information note and signed consent,
  15. Reproductive age patients agreeing to use two methods of birth control (one for the patient and one for the partner) for the duration of the study and for 6 months after the last dose of treatment,
  16. Patients able to comply with the protocol requirements (scheduled visits, treatment plan, clinical, paraclinical, biological and other procedures of the Protocol)
  17. Patients undergoing a social security scheme.

Exclusion Criteria:

  1. Fixed inguinal lymph nodes (cN3)
  2. Iliac lymph nodes (cN3)
  3. Patients pN3
  4. prior chemotherapy for squamous cell carcinoma of the penis,
  5. Against-indication for chemotherapy or known hypersensitivity to cisplatin, ifosfamide or paclitaxel,
  6. Patients treated with phenytoin,
  7. Patients with hearing loss> Grade 1 (CTC-AE V4.03)
  8. Patients with cardiopulmonary disease-indicating against overhydration,
  9. History of cancer within 5 years prior to inclusion in the trial other than cutaneous basal cell,
  10. Patient received a live attenuated vaccine within 30 days prior to inclusion,
  11. Patients already included in another clinical trial or receiving an experimental treatment within 30 days prior to inclusion in the trial,
  12. Patients deprived of their lyberty or under court protection including guardianship,
  13. Severe systemic disease or uncontrolled or any other chronic or acute illness that is incompatible with the patient's participation in the trial according to investigator,
  14. immunocompromised patients including with known seropositivity (HIV),
  15. Patients with mental impairment which prevents the understanding of the protocol or having a psychological state, family, sociological or geographical conditions that would not allow compliance with the protocol and the planned follow-up or any condition which, according to the investigator, would prevent participation patient tested. These conditions should be assessed before inclusion of patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817958


Contacts
Contact: Sandra PELISSIER +33(0)144235568 s-pelissier@unicancer.fr

Locations
France
ICO-Paul Papin Recruiting
Angers, France, 49055
Contact: Emmanuelle BOMPAS, Doctor    +33(0)2 41 35 27 00    emmanuelle.bompas@ico.unicancer.fr   
Chr Besancon Recruiting
Besançon, France, 25000
Contact: Tristant MAURINA, Doctor    +33(0)3 81 66 93 67    t1maurina@chu-besancon.fr   
Hôpital SAINT ANDRE Recruiting
Bordeaux, France, 33075
Contact: Amaury DASTE, Doctor       amaury.daste@chu-bordeaux.fr   
Centre FRANCOIS BACLESSE Recruiting
Caen, France, 14076
Contact: Florence JOLY, Prof    +33 2 31 45 50 02    f.joly@baclesse.unicancer.fr   
Chru Gabriel Montpied Recruiting
Clermont Ferrand, France, 63000
Contact: Laurent GUY, Professor    +33(0)4 73 75 14 97    lguy@chu-clermontferrand.fr   
Ch de Limoges Recruiting
Limoges, France, 87042
Contact: Aurélien DESCAZEAUD, Professor    +33(0)5 55 05 80 15    aurelien.descazeaud@chu-limoges.fr   
Centre Leon Berard Recruiting
Lyon, France, 69008
Contact: Aude FLECHON, Doctor    +33(0)4 78 78 26 43    aude.flechon@lyon.unicancer.fr   
Chu Lyon Sud Recruiting
Lyon, France, 69310
Contact: Jean-Etienne TERRIER, Dr    +33 4 72 67 88 01    jean-etienne.terrier01@chu-lyon.fr   
Institut Paoli-Calmettes Recruiting
Marseille, France, 13273
Contact: Gwenaelle GRAVIS, Doctor    +33(0)4 91 22 37 40    gravisg@ipc.unicancer.fr   
Institut de Cancerologie de Lorraine Recruiting
Nancy, France, 54519
Contact: Vincent MASSARD, Dr    +33 3 23 59 84 61    v.massard@nancy.unicancer.fr   
Clinique Urologique- Chu Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Jérôme RIGAUD, Professor    +33(0)2 40 08 39 10    jrigaud@chu-nantes.fr   
Institut de Cancerologie Du Gard - Centre Oncogard Recruiting
Nîmes, France, 300029
Contact: Angélique CHAPELLE, Doctor    +33(0)4 30 06 10 14    a.chapelle@oncogard.com   
Hopital Saint Louis Recruiting
Paris, France, 75010
Contact: Stéphane CULINE, Professor    +33(0)1 42 49 42 47    stephane.culine@aphp.fr   
Chu de Rouen Recruiting
Rouen, France, 76031
Contact: Christian PFISTER, Professor    +33(0)2 32 88 81 63    christian.pfister@chu-rouen.fr   
ICO-René Gauducheau Recruiting
saint Herblain, France, 44805
Contact: Emmanuelle BOMPAS, Doctor    +33(0)2 40 67 97 00    emmanuelle.bompas@ico.unicancer.fr   
Hopitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Philippe BARTHELEMY, Doctor       philippe.barthelemy@chru-strasbourg.fr   
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: Loic MOUREY, Doctor    +33(0)5 31 15 51 67    mourey.loic@iuct-oncopole.fr   
Sponsors and Collaborators
UNICANCER
National Cancer Institute, France
Investigators
Principal Investigator: Jérôme Rigaud, Professor CHU de Nantes

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02817958     History of Changes
Other Study ID Numbers: UC-0160/1406
AFU-GETUG 25 ( Other Identifier: Unicancer )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by UNICANCER:
inguinal lymph nodes
penile cancer
squamous
TIP chemotherapy

Additional relevant MeSH terms:
Penile Diseases
Carcinoma
Carcinoma, Squamous Cell
Penile Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male