The study objective:
- To evaluate the response and survival rates after treating stage III cervical cancer
with retinoic acid and interferon-α combined with radiotherapy in the study group.
- To evaluate the response and survival rates after treating stage III cervical cancer
patients with concomitant cisplatin and radiotherapy in the control group.
- To evaluate the safety and tolerability of the combination of retinoic acid,
interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.
- To determine if there is an immune response to Human Papillomavirus (HPV) by estimating
serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and
after treatment.
The study hypothesis:
- The response rates and survival rates of retinoic acid and interferon-α combination with
radiation will be better than chemo-radiation to treat stage III cervical cancer.
- Treatment with the retinoic acid, interferon-α and radiation combination therapy will be
less toxic and better tolerated than chemo-radiation therapy.
Phase:
Phase 2
Details
Lead Sponsor:
James Graham Brown Cancer Center University of Louisville
Collaborators:
James Graham Brown Cancer Center University of Louisville