Radiation Therapy: Standard of Care Chemoradiation for Cervical cancer patients in India.
Study summary
The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* patients with newly biopsy proven squamous carcinoma or adenocarcinoma of the uterine cervix, FIGO stage IB2-IIIB in whom curative CTRT is planned
* Karnofsky performance status ≥ 70
* Patients with lower paraortic lymph nodes (below the level of L2 vertebra)
* patients diagnosed with cervical cancer whom also HIV positive or HIV negative
Exclusion Criteria:
* patients with active tuberculosis
Primary outcome measure(s)
Completion Rates of Cancer Treatment — 2 years To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients.
Treatment adherence is defined as receiving at least 5 cycles of weekly cisplatin chemotherapy and completion of all prescribed radiation (including brachytherapy) and chemotherapy within 8 weeks of treatment initiation.
Impact of HIV Infection on acute toxicities — 2 years To compare the incidence of acute grade ≥3 gastrointestinal, genitourinary and hematological toxicities using CTCAE v4 in patients receiving concurrent cisplatin-based chemo-radiation and brachytherapy for cervical cancer in HIV positive and HIV negative patients. Acute toxicities include any toxicity occurring within 90 days of treatment completion.
Trial sites (1)
Facility
City
Region
Status
Tata Memorial Hospital
Mumbai
Maharashtra
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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