Neoadjuvant Chemotherapy in Non Muscle Invasive T1b Bladder Cancer

NCT04245618 | Unknown

• 1 other identifier: NAC in T1 Bladder cancer
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study is to evaluate the benefit of NAC in T1b NMIBC .

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of the benefit of NAC in T1b NMIBC .

  assessment of the response in correlation with high risk features.

  baseline

Secondary Outcomes (1)

• Overall survival (OS) and disease-specific survival (DSS).

  2 years

Interventions

neoadjuvant chemotherapy ( cisplatin - gemcitabine) DRUG

Neoadjuvant chemotherapy before TURBT

Also known as: cisplatin - gemzar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years confirmed to have T1b Non muscle invasive bladder cancer by biopsy will take neoadjuvant chemotherapy

You may qualify if:

• Patient who are older than 18 years old.
• Histologically confirmed to have Non-muscle invasive bladder cancer, T1bN0M0 ,clinically and radiologically confirmed to have bladder cancer.
• Patient should have Eastern Cooperative Oncology Group performances status (ECOG)0-1 with adequate hematologic, hepatic and renal functions including hemoglobin\>10 /dl, absolute neutrophil count ≥1,500/mm3, platelets ≥100,000/mm3, serum bilirubin \<2 mg/dl ,both Alanine transaminase( ALT) and aspartate aminotransferase( AST) ≤2× upper limit of normal (ULN), alkaline phosphates ≤5×ULN,and serum creatinine ≤1.5 mg/dl or creatinine clearance ≥60 ml/min.

You may not qualify if:

• Patients with radiographic evidence of nodal or distant metastases.
• A past history of upper tract disease, neuroendocrine features.
• Non-cisplatin-based NAC .
• Prior radiation therapy to their pelvis.
• A palpable three-dimensional mass on EUA.
• Known to be stage 0, T1a, II, III, IV.
• Active serious infection, or a psychiatric illness that would preclude obtaining informed consent or history of cardiac disease will be excluded.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Cambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guerin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23.

  PMID: 26210894 BACKGROUND

• Tarin TV, Power NE, Ehdaie B, Sfakianos JP, Silberstein JL, Savage CJ, Sjoberg D, Dalbagni G, Bochner BH. Lymph node-positive bladder cancer treated with radical cystectomy and lymphadenectomy: effect of the level of node positivity. Eur Urol. 2012 May;61(5):1025-30. doi: 10.1016/j.eururo.2012.01.049. Epub 2012 Feb 7.

  PMID: 22342773 BACKGROUND

• Chahal R, Harrison SC. Re: an interval longer than 12 weeks between the diagnosis of muscle invasion and cystectomy is associated with worse outcome in bladder carcinoma. J Urol. 2003 Oct;170(4 Pt 1):1327; author reply 1327. No abstract available.

  PMID: 14515867 BACKGROUND

• Black PC, Brown GA, Dinney CP. The impact of variant histology on the outcome of bladder cancer treated with curative intent. Urol Oncol. 2009 Jan-Feb;27(1):3-7. doi: 10.1016/j.urolonc.2007.07.010. Epub 2008 Jan 14.

  PMID: 18367107 BACKGROUND

• Otto W, van Rhijn BW, Breyer J, Bertz S, Eckstein M, Mayr R, Lausenmeyer EM, Denzinger S, Burger M, Hartmann A. Infiltrative lamina propria invasion pattern as an independent predictor for cancer-specific and overall survival of instillation treatment-naive stage T1 high-grade urothelial bladder cancer. Int J Urol. 2018 May;25(5):442-449. doi: 10.1111/iju.13532. Epub 2018 Feb 22.

  PMID: 29473226 BACKGROUND

• Babjuk M, Burger M, Comperat EM, Gontero P, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Sylvester R, Zigeuner R, Capoun O, Cohen D, Escrig JLD, Hernandez V, Peyronnet B, Seisen T, Soukup V. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update. Eur Urol. 2019 Nov;76(5):639-657. doi: 10.1016/j.eururo.2019.08.016. Epub 2019 Aug 20.

  PMID: 31443960 BACKGROUND

• Martin-Doyle W, Leow JJ, Orsola A, Chang SL, Bellmunt J. Improving selection criteria for early cystectomy in high-grade t1 bladder cancer: a meta-analysis of 15,215 patients. J Clin Oncol. 2015 Feb 20;33(6):643-50. doi: 10.1200/JCO.2014.57.6967. Epub 2015 Jan 5.

  PMID: 25559810 BACKGROUND

• Yoshida S, Koga F, Kobayashi S, Ishii C, Tanaka H, Tanaka H, Komai Y, Saito K, Masuda H, Fujii Y, Kawakami S, Kihara K. Role of diffusion-weighted magnetic resonance imaging in predicting sensitivity to chemoradiotherapy in muscle-invasive bladder cancer. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):e21-7. doi: 10.1016/j.ijrobp.2011.11.065. Epub 2012 Mar 11.

  PMID: 22414281 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• hoda essa, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Heba sheha, MD

CONTACT

+201005054776; beboo0412@gmail.com

abeer fayek, professor

CONTACT

Abeeramin210@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: January 29, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 30, 2020

Record last verified: 2020-01