Clinical trial · Interventional
Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Transitional Cell Carcinoma of the Bladder | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| vinblastine sulfate | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (immediate chemotherapy)
- description
- Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
- interventionNames
- Drug: doxorubicin hydrochloride
- Drug: gemcitabine hydrochloride
- Drug: vinblastine sulfate
- Drug: methotrexate
- Drug: cisplatin
- Biological: filgrastim
- type
- EXPERIMENTAL
- label
- Arm II (deferred chemotherapy)
- description
- Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
- interventionNames
- Drug: doxorubicin hydrochloride
- Drug: gemcitabine hydrochloride
- Drug: vinblastine sulfate
- Drug: methotrexate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed transitional cell carcinoma of the bladder urothelium * T3-4, N1-3, M0 * No pure squamous cell or adenocarcinoma tumors * No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy without evidence of microscopic residual disease * Performance status - WHO 0-1 * WBC at least 3,500/mm\^3 * Platelet count at least 120,000/mm\^3 * SGOT/SGPT less than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 2.5 times ULN * Bilirubin normal * Glomerular filtration rate greater than 60 mL/min * No clinically significant cardiac arrhythmia * No congestive heart failure * No complete bundle branch block * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study * Considered fit for cisplatin-containing combination chemotherapy * No clinically abnormal auditory function * No known hypersensitivity to E. coli-derived drug preparations * No grade 2 or greater peripheral neuropathy * No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer (pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL) * No psychological, familial, sociological, or geographical condition that would preclude study involvement * No prior systemic chemotherapy * No prior radiotherapy to the bladder
References
Publications (1)
- DERIVEDSternberg CN, Skoneczna I, Kerst JM, Albers P, Fossa SD, Agerbaek M, Dumez H, de Santis M, Theodore C, Leahy MG, Chester JD, Verbaeys A, Daugaard G, Wood L, Witjes JA, de Wit R, Geoffrois L, Sengelov L, Thalmann G, Charpentier D, Rolland F, Mignot L, Sundar S, Symonds P, Graham J, Joly F, Marreaud S, Collette L, Sylvester R; European Organisation for Research and Treatment of Cancer Genito-Urinary Cancers Group; Groupe d'Etude des Tumeurs Urogenitales; National Cancer Research Institute Bladder Cancer Study Group; National Cancer Institute of Canada Clinical Trials Group; German Association of Urologic Oncology. Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3-pT4 or N+ M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open-label, randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):76-86. doi: 10.1016/S1470-2045(14)71160-X. Epub 2014 Dec 11. PMID 25498218