Health Condition 1: C241- Malignant neoplasm of ampulla of Vater
Conditions
Interventions
Intervention1: Adjuvant chemotherapy followed by chemoradiation: Intestinal subtype: 3 cycles CAPOX followed by Concurrent chemoradiation (50.4Gy) with
capecitabine (daily 1650mg/m2) followed by 3 mo
Sponsors
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have undergone radical resection of ampullary carcinoma (R0). Stage 2 and 3 Have an Karnofsky performance status of 80-90. Must be able to start treatment within 6 weeks of surgery Have normal organ and marrow function. No evidence of infection Weight loss not exceeding 10% in the preceding 3 months
Exclusion criteria
Exclusion criteria: 1. R1 resection 2. Non-radical surgery 3. Node negative disease 4. Serious co-existing medical condition likely to interfere with protocol treatment, including a potential serious infection 5. Evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the disease-free survival of patients in both armsTimepoint: 1 year, 2 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the overall survival of patients in both arms. To compare acute toxicity between the 2 arms. To compare the QOL (FACT QOL) in both arms.Timepoint: 1-yr, 2-yr | — |
Countries
India
Contacts
Public ContactSushma Agrawal
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Outcome results
None listed