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Active, Not Recruiting

NCT Number: NCT07167069

India HIV-CervCa Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Positive Blood-Borne Infections Cervical Cancer Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections HIV Negative HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

About this study

This study will compare chemoradiation completion rates for cervical cancer in two groups, women with HIV and women without HIV. The investigators will also be analyzing tumor tissue for tumor infiltrating lymphocytes which are thought to be involved in disease progression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Standard of Care Chemoradiation for Cervical cancer patients in India.

Primary outcomes

  1. Completion Rates of Cancer Treatment

    Time frame: 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.

  2. Impact of HIV Infection on acute toxicities

    Time frame: 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.

Secondary outcomes

  1. Tumor infiltrating lymphocytes (TILs)

    Time frame: 2 Years

    To identify and characterize tumor infiltrating lymphocytes (TILs) with reference to numbers and phenotype in tumor biopsies of HIV positive and HIV negative cervical cancer patients in India

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Tata Memorial Hospital

Registry information

Official study title

Comparison of Treatment Adherence and Toxicities of HIV Positive Patients Versus HIV Negative Cervical Cancer Patients in India

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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