CTRI/2018/04/013507
Not yet recruiting
Phase 3
A Randomized study comparing Weekly Paclitaxel plus Best Supportive Care with Best Supportive Care Alone in Patients with small cell lung cancer relapsed on two or more lines of chemotherapy.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients with small cell lung cancer relapsed on two or more lines of chemotherapy
- Sponsor
- Tata Memorial Hospital
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Histologically or cytologically proven SCLC
- •2\.Age over 18 years
- •3\.Patient should have received at least two lines of systemic therapy and therapy should have been stopped due to progressive disease or intolerable side\-effects. Chemotherapy received concurrently with radiotherapy may be considered as one line of systemic therapy.
- •4\.Eastern cooperative oncology group (ECOG) performance status \< 2
- •5\.Willing to provide written, informed consent.
- •6\.Baseline laboratory parameters within acceptable limits, including
- •a.Hemoglobin \> 8 g/dl
- •b.Absolute neutrophil count \> 1\.5 x 10e9/L and total leucocyte counts \> 3\.5 x 10e9/L
- •c.Baseline liver function tests:
- •i.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN)
Exclusion Criteria
- •1\.Serious co\-morbidities such as, but not limited to severe cardiac failure or severe pulmonary compromise or severe and active infections.
- •2\.Peripheral neuropathy \> grade 2\.
- •3\.Patient has received paclitaxel chemotherapy.
- •4\.Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable.
- •5\.Patients on other investigational drugs within the last 30 days.
- •6\.Women of child\-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
Comparison of efficacy of Paclitaxel with Cisplatin when given weekly along with radiation in patients suffering from Head and Neck cancers.CTRI/2017/09/009864Jawaharlal Institute of Post Graduate Medical Education and Research54
Recruiting
Not Applicable
Prospective randomized trial comparing paclitaxel releasing balloon with everolimus eluting stent for the small coronary vesselscoronary artery diseaseJPRN-UMIN000033709The Juntendo University Nerima Hospital Department of Cardiology322
Completed
Not Applicable
A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel diseaseJPRN-UMIN000026760ipro Corporation135
Recruiting
Not Applicable
Randomized Evaluation of Paclitaxel-eluting versus Everolimus-eluting stent Trialcoronary artery diseaseJPRN-UMIN000004177Division of Cardiovascular Medicine, Wakayama Medical University800
Recruiting
Phase 2
A study of low intensity chemotherapy in relapsed and refractory lymphoma patientsHealth Condition 1: C817- Other Hodgkin lymphomaHealth Condition 2: C858- Other specified types of non-Hodgkin lymphomaCTRI/2020/08/026992Jawaharlal Institute Post Graduate Medical Education and Research