Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

NCT ID: NCT03750539

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2025-11-10

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.

Detailed Description

Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively evaluated, including urinary, hematologic and dermatologic, this data will allow to determining the effect of hypofractionated radiation therapy on each of these aspects of toxicity from pelvic radiation. Additionally, will be recognized that it is possible to advance in the understanding of the clinical risk and benefits of hypofractionation.

The primary endpoint will be acute gastrointestinal toxicity using the Radiation Therapy Oncology Group (RTOG) common toxicity criteria.

In total, evaluating toxicity in different time points will allow determining if hypofractionation is secure concerning acute and late toxicity, that would enable to offer an optional treatment to this kind of patient. Chronic gastrointestinal toxicity from radiation continues to increase rapidly over two years, and then the rate of developing new toxicities slows. As a result, the majority of chronic radiation-induced gastrointestinal toxicity by evaluating toxicity two years after completion of radiotherapy is going to be identified.

Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both of which have been validated and available in Mexican Spanish.

Conditions

Cervix Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Treatment

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

Group Type: ACTIVE_COMPARATOR

Standard radiotherapy

Intervention Type: RADIATION

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

Radical hysterectomy

Intervention Type: PROCEDURE

Radical hysterectomy and pelvic and paraaortic lymph node resection

hypofractionated treatment

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

Group Type: EXPERIMENTAL

hypofractionated radiotherapy

Intervention Type: RADIATION

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

Radical hysterectomy

Intervention Type: PROCEDURE

Radical hysterectomy and pelvic and paraaortic lymph node resection

Interventions

Standard radiotherapy

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

Intervention Type: RADIATION

hypofractionated radiotherapy

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

Intervention Type: RADIATION

Radical hysterectomy

Radical hysterectomy and pelvic and paraaortic lymph node resection

Intervention Type: PROCEDURE

Other Intervention Names

Surgery

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cancerología

OTHER_GOV

Sponsor Role: lead

Responsible Party

David Cantu

Chief of clinical trial departament

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia, Columbia

Locations

David Cantu de Leon

Mexico City, Tlalpan, Mexico

Site Status: ACTIVE_NOT_RECRUITING

Instituto Nacional de Cancerologia

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

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

Role: CONTACT

dfcantu@gmail.com

+5215537093156

Lennt N Gallardo-Alvarado, MD, Msc

Role: CONTACT

dra.ngallardo@yahoo.com

+521553702118

Facility Contacts

David F Cantu de Leon, MD, PhD

Role: primary

dfcantu@gmail.com

525556280400 ext. 21016

Lenny N Gallardo-Alvarado, MD, MSc

Role: backup

dra.ngallardo@yahoo.com

525556280400 ext. 37000

Other Identifiers

017/020/ICI

Identifier Type: -

Identifier Source: org_study_id