Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

NCT03750539 | Unknown

• 1 other identifier: 017/020/ICI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.

Conditions

Cervix Cancer

Outcome Measures

Primary Outcomes (1)

• Acute and late toxicity.

  Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG

  2 years

Secondary Outcomes (4)

• Overall survival

  2 years

• disease specific survival

  2 years

• equivalent treatment

  2 years

• Surgical complications

  1 year

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

External Beam pelvic radiation therapy daily dose of 1.8-2 Gray (Gy) per session for 25 sessions to accomplish 45 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation

Radiation: Standard radiotherapy; Procedure: Radical hysterectomy

hypofractionated treatment

EXPERIMENTAL

External Beam pelvic radiation therapy daily dose of 1.8-2gy per session for 15 sessions to accomplish 37.5 Gy Chemotherapy ( cisplatin 40mg/m2), intravenous administration of chemotherapy once a week in an hour infusion Type II or type III open radical hysterectomy after 4-6 weeks after completion of external beam radiation

Radiation: hypofractionated radiotherapy; Procedure: Radical hysterectomy

Interventions

Standard radiotherapy RADIATION

External Bean Pelvic Radiation: 50 Gy in 15 fractions, with weekly cisplatin.

Standard Treatment

hypofractionated radiotherapy RADIATION

External Bean Pelvic Radiation: 37.5 Gy in 15 fractions, with weekly cisplatin.

hypofractionated treatment

Radical hysterectomy PROCEDURE

Radical hysterectomy and pelvic and paraaortic lymph node resection

Also known as: Surgery

Standard Treatment; hypofractionated treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outside of the pelvis by via ultrasound.
• No distant metastasis via chest X-ray.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Age 18
• complete blood count (CBC)/differential obtained 14 days before study entry with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mim3
• Platelets 100,000 cells/mim3
• Hemoglobin 8.0 g/dl
• White blood count 4000 cell/m3
• An adequate renal function defined as follows:
• Serum creatinine 1.5 mg/dl within 14 days before study entry
• Patients with known HIV positive must have a cluster of differentiation 4 (CD4) T lymphocytes count be 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol). Excluding HIV positive patients with invasive cervical cancer and low CD4 cell counts is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
• Chest x-ray and ultrasound must be performed within 12 (8 or 12) weeks before the study enrollment (I took out the ct scan of abdomen and pelvis)
• Patient must provide study-specific informed consent before study entry.

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast or oral cavity.
• Patients cannot have any neuroendocrine histology in pathology.
• Prior systemic chemotherapy for the current cervical cancer, note that prior chemotherapy for a different cancer is allowable.
• Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields.
• Severe active co-morbidity, defined as follows:
• Unstable angina or congestive heart failure requiring hospitalization within the last six months.
• Transmural myocardial infarction within the previous six months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of the study entry.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry.
• Coagulation defects; note, however, that coagulation parameter are not required for entry into this protocol.
• Prior allergic reaction to cisplatin or other platinum drugs.
• Patients with para-aortic nodes or distant metastasis.

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (2)

David Cantu de Leon

Mexico City, Tlalpan, 14080, Mexico

ACTIVE NOT RECRUITING

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiation Dose Hypofractionation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• David F Cantu-de Leon, MD, Msc, PhD

  Instituto Nacional de Cancerologia, Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David F Cantu-de Leon, MD, MSC, PhD

CONTACT

+5215537093156; dfcantu@gmail.com

Lennt N Gallardo-Alvarado, MD, Msc

CONTACT

+521553702118; dra.ngallardo@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of clinical trial departament

Model Details: Phase II Comparative Randomized Open-label

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 23, 2018
• Study Start: November 10, 2017
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: the data will be shared with scientific and academic institutions or research groups that study the same topic and with the regulatory and ethical authorities that require it, to ensure the quality and accuracy of the data.

Locations

ME (2)