- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Delhi
-
New Delhi, Delhi, Indien, 110029
- Rekrytering
- All India Institute of Medical Sciences
-
Kontakt:
- Subrat K Acharya, DM
- Telefonnummer: 4934 91-112658500
- E-post: subratacharya2004@yahoo.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Supportive
Supportive therapy
|
No specific therapy will be given
Andra namn:
|
Aktiv komparator: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Överlevnad
Tidsram: 1 år
|
1 år
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Livskvalité
Tidsram: 1 år
|
1 år
|
|
Tumour response
Tidsram: 1 year
|
1 year
|
|
Number of patients with side effects
Tidsram: 1 year
|
Patients developing various adverse events will be recorded
|
1 year
|
Change from baseline in Child status at 1 year
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Subrat K Acharya, DM, All India Institute of Medical Sciences, New Delhi
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ICMR- D.O No.5/8/7/26/99-ECD-1
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