- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01438450
Oral Chemotherapy Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma (OTCHCC)
RCT Of Oral Thalidomide And Capecitabine Versus Supportive Therapy In The Treatment Of Unresectable Hepatocellular Carcinoma (BCLC D)
Přehled studie
Detailní popis
Aim The aim of the study is to compare the effect of Oral chemotherapeutic drugs (Thalidomide and Capecitabine) in comparison with supportive therapy in the treatment of advanced Hepatocellular carcinoma in a randomized controlled trial.
Setting The study would be conducted at the All India Institute of Medical Sciences, New Delhi, a tertiary care teaching hospital, in the departments of Gastroenterology and Radiodiagnosis.
Diagnostic criteria
- Cirrhosis of liver- Diagnosis will be founded on the basis of clinical, biochemical, imaging and endoscopy findings.
Hepatocellular carcinoma- when any one of the following is present
- Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced MRI) showing arterialization of the hepatic mass
- AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
- Fine needle aspiration cytology (FNAC)
Definitions
Advanced HCC-(BCLC D) Liver mass (solitary or multiple)with vascular involvement with any of the following
- extrahepatic disease
- distant metastasis
- PST score >2
Barcelona Clinic Liver Cancer (BCLS) staging is based on the BCLC classification (Llovet JM et al. Lancet 2003). Liver cancer is staged into BCLC A- D according to this classification.
Tumor response: Based on DP contrast-enhanced computed tomography (CECT) done every 1, 3, 6 months after starting oral chemotherapy the response will be graded into the following- Complete response (CR): Tumor resolved completely Partial response (PR): Tumor size decreased >50% (product of 2 large diameters) Minor response (MR): Tumor size decreased 25 - 50% Stable disease (SD): Tumor size + 25% No response (NR): No change Disease progression Fresh lesions or recurrence
Patient tolerance Grade 1: no side effects Grade 2: moderate side effects Grade 3: severe side effects Grade 4: life threatening side effects
Performance status (PST score) PST score of 0-4 would be assessed on the following basis 0- No cancer related symptoms. Normal life style
- Minor symptoms related to cancer. Capable of non-strenuous activity.Fully ambulatory and capable of all self-care but unable to carry out any work activities. Confined to bed less than 50% of waking hours
- Capable of only limited self-care. Confined to bed more than 50% of waking hours.
- Completely disabled. Cannot carry on any self-care. Totally confined to bed.
- Dead
Sample Size Earlier studies have shown 1-year response rate of 10% for doxorubicin and 25% response rate for thalidomide. Combining these two drugs, 25% response rate is taken in the oral chemotherapy group, 37 patients are needed in each group. (Total 74 pts)
Randomization
- Patients will be randomized after the confirmation of diagnosis and obtaining written consent
- Sequences will be generated by the Statistician
- Randomization will be done by drawing consecutively numbered opaque sealed envelopes
Follow up Clinical follow up
- All patients would be followed up in the Liver clinic monthly unless their clinical condition warrants earlier follow up
- Liver function tests/ complete blood count would also be done at each visit and Alpha fetoprotein (AFP) (if elevated earlier) every six months
- Patient tolerance, child's status would be estimated.
- Side effects to the drugs would be noted.
Imaging follow up
- At one month, a dual phase CT would be done to ascertain the response to therapy and the need to repeat the procedure. Subsequently, the DPCT would be done at 3 and 6 monthly intervals in the arm receiving oral chemotherapy.
Duration of follow up- one year after starting chemotherapy
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní místa
-
-
Delhi
-
New Delhi, Delhi, Indie, 110029
- Nábor
- All India Institute of Medical Sciences
-
Kontakt:
- Subrat K Acharya, DM
- Telefonní číslo: 4934 91-112658500
- E-mail: subratacharya2004@yahoo.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patients above 12 years of age with
- ECOG performance status (PST) score of 3 or above
- Underlying Child's A and B cirrhosis
- More than 50% involvement of liver by tumor
- Thrombosed main portal vein
- HV/IVC thrombosis
- Extra hepatic disease
- Metastatic disease
- Informed written consent of patient
Exclusion Criteria:
- History of drug allergy
- Co-morbid illness like coronary artery disease, congestive heart failure, chronic renal failure etc
- Pregnancy
- Outstation patients from distant areas not in a position to follow up
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: Supportive
Supportive therapy
|
No specific therapy will be given
Ostatní jména:
|
Aktivní komparátor: Oral
Oral thalidomide and capecitabine
|
Capecitabine : 500 mg OD x 1 week 500 mg BD x 1 week 500 mg (2 morning, 1 evening) x 1 week After attaining the max dose of 1500 mg, a cycle of Capecitabine 1500mg every day for 2 weeks and 1 week off to be maintained. Thalidomide: 50 mg OD x 1 week 100 mg OD x 1 week 200 mg OD x 1 week, 300 mg OD x 1 week
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Přežití
Časové okno: 1 rok
|
1 rok
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Kvalita života
Časové okno: 1 rok
|
1 rok
|
|
Tumour response
Časové okno: 1 year
|
1 year
|
|
Number of patients with side effects
Časové okno: 1 year
|
Patients developing various adverse events will be recorded
|
1 year
|
Change from baseline in Child status at 1 year
Časové okno: 1 year
|
Child status is calculated from the following 5 parameters
Child A: score 5-6, Child B: 7-9 and Child C: 10 or more |
1 year
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Subrat K Acharya, DM, All India Institute of Medical Sciences, New Delhi
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ICMR- D.O No.5/8/7/26/99-ECD-1
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