Health Condition 1: null- Patients with high-risk node positive carcinoma penis that have undergone complete surgical resection and are planned for adjuvant chemotherapy
Conditions
Interventions
Intervention1: 5 -Fluorouracil and Platinum: 4 cycles of 5 -Fluorouracil 1000mg/m2 and platinum (Cisplatin 75mg/m2 If creatinine clearance is less than 50 cc/min carboplatin will be administered at a
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 2.Histological or cytological proven diagnosis of squamous cell carcinoma of the penis 3.Patient has undergone definitive surgery (R0 or R1 resection) for CA penis with nodal dissection. 4.Pathologically proven lymph node positive for more than one inguinal lymph node involvement or perinodal extension or at least one pelvic lymph node involvement or > 4 cm tumor in a lymph node. 5.Suitable for adjuvant therapy. 6.Performance status 0-2. 7.No evidence of distant metastases. 8.Normal bone marrow reserve (within 2 weeks of randomization) defined as, - WBC > 3000/cumm Platelets > 100,000/cumm Hb > 9 gm/dl 9.Patient must give valid informed consent prior to treatment
Exclusion criteria
Exclusion criteria: 1.Prior invasive malignancy (except non-melanoma skin cancer or in-situ cervical cancer), that is in remission for less than 3 years. 2.R2 resection of the groin or pelvic regional nodes. 3.Unhealthy wound/ significant local infection/ discharging sinuses, which have been inadequately treated. 4.Peripheral neuropathy > grade 2 5.Patients who have received any neoadjuvant/ induction chemotherapy 6.History of severe hypersensitivity to paclitaxel, carboplatin or cisplatin and 5FU. 7.Uncontrolled co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections. 8.Presence of distant metastatic disease. 9.Life expectancy less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Over all survival 2.Time to tumor progression 3.Toxicity 4.Locoregional Control 5. Quality of LifeTimepoint: 1.1 Year 2.1 Year 3.At Each visit 4.1 Year 5.Baseline,on day 7-10 after starting chemotherapy,6weeks after starting adjuvant chemotherapy,completion of treatment,at each follow up visit,at end of study visit | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed