Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer

Conditions

Locally Advanced Bladder Cancer

Keywords

locally advanced bladder cancer, Postoperative radiotherapy, Adjuvant chemotherapy, Radical Cystectomy

Brief summary

Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.

Mohamed S. Zaghloul, John P. Christodouleas, Tarek Zaghloul, Ahmed Abdalla, Hany William et al. (8 authors)

Journal of Clinical Oncology2020-02-192 citations

10.1200/jco.2020.38.6_suppl.524

Prospective trial of adjuvant chemotherapy versus adjuvant radiation therapy for locally advanced bladder cancer after radical cystectomy.

Mohamed S. Zaghloul, John P. Christodouleas, Tarek Zaghloul, Andrew M. Smith, Ahmed Abdalla et al. (9 authors)

Journal of Clinical Oncology2020-02-192 citations

10.1200/jco.2020.38.6_suppl.515

Randomized trial of adjuvant chemotherapy versus adjuvant radiation therapy for locally advanced bladder cancer after radical cystectomy.

Mohamed S. Zaghloul, John P. Christodouleas, Tarek Zaghloul, Andrew R. Smith, Ahmed N. Abdalla et al. (8 authors)

Journal of Clinical Oncology2019-05-205 citations

10.1200/jco.2019.37.15_suppl.4507

Adjuvant Sandwich Chemotherapy Plus Radiotherapy vs Adjuvant Chemotherapy Alone for Locally Advanced Bladder Cancer After Radical Cystectomy

Mohamed S. Zaghloul, John P. Christodouleas, Andrew M. Smith, Ahmed Abdallah, Hany William et al. (8 authors)

JAMA Surgery2017-11-2988 citations

10.1001/jamasurg.2017.4591

A randomized clinical trial comparing adjuvant radiation versus chemo-RT versus chemotherapy alone after radical cystectomy for locally advanced bladder cancer.

Mohamed S. Zaghloul, John P. Christodouleas, Andrew M. Smith, Ahmed Abdalla, Hany William et al. (8 authors)

Journal of Clinical Oncology2016-01-1016 citations

10.1200/jco.2016.34.2_suppl.356

Interventions

RADIATIONRadiation

DRUGgemcitabine and cisplatin

OTHERRadiotherapy and Drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* Patients not more than 70 years old. * Radical cystectomy performed within 42 days with no microscopic or macroscopic residual after surgery (negative surgical safety margins) * Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN) * ECOG Performance Scale (0-2). * Adequate liver functions. * Adequate renal function serum (creatinine \< 1.5 mg). * No evidence of distant metastasis or other malignancy.

Exclusion criteria

* patients who received radiotherapy or chemotherapy prior to radical cystectomy

Design outcomes

Primary

Measure	Time frame	Description
Comparison of the disease-free survival and overall survival of post-operative radiotherapy , adjuvant chemotherapy and the combined modalities [radiotherapy and chemotherapy] after radical cystectomy	Five-year overall and disease-free survival.	Regular follow up is performed every 2 months in the first 2 years postcystectomy and every 6 months thereafter. Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.

Secondary

Measure	Time frame	Description
comparison of the Local recurrence rate in the three Arms	Five year local pelvic control rate	Periodical CT pelvis is performed every 6 months in the first 2 years and yearly thereafter. The other appropriate radiological studies are performed in response to patients' symptoms and signs. Treatment side effects (immediate and late) are reported in each follow up visit.

Countries

Egypt

Outcome results

None listed