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Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

Primary Purpose

Cervix Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Standard radiotherapy

hypofractionated radiotherapy

Radical hysterectomy

About this trial

This is an interventional treatment trial for Cervix Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

David Cantu de Leon
Instituto Nacional de CancerologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Treatment

hypofractionated treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Acute and late toxicity.

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

Secondary Outcome Measures

Overall survival

Number of Participants dead at two years according to kaplan-meyer analysis

disease specific survival

Number of Participants dead of disease at two years according to kaplan-meyer analysis

equivalent treatment

hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment.

Surgical complications

comparison of surgical complications between the two arms of treatment according to The Clavien-Dindo classification.

Full Information

NCT ID

NCT03750539

First Posted

November 5, 2018

Last Updated

March 18, 2021

Sponsor

National Institute of Cancerología

1. Study Identification

Unique Protocol Identification Number

NCT03750539

Brief Title

Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

Official Title

Phase II Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With Standard Fractionated Compared to Hypofractionated Followed by Surgery for Patients With Locally Advanced Cervical Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 10, 2017 (Actual)

Primary Completion Date

November 10, 2021 (Anticipated)

Study Completion Date

November 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of Cancerología

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervix Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Phase II Comparative Randomized Open-label

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Treatment

Arm Type

Active Comparator

Arm Description

Arm Title

hypofractionated treatment

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Standard radiotherapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

hypofractionated radiotherapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Radical hysterectomy

Other Intervention Name(s)

Surgery

Intervention Description

Radical hysterectomy and pelvic and paraaortic lymph node resection

Primary Outcome Measure Information:

Title

Acute and late toxicity.

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

Number of Participants dead at two years according to kaplan-meyer analysis

Time Frame

2 years

Title

disease specific survival

Description

Number of Participants dead of disease at two years according to kaplan-meyer analysis

Time Frame

2 years

Title

equivalent treatment

Description

hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment.

Time Frame

2 years

Title

Surgical complications

Description

comparison of surgical complications between the two arms of treatment according to The Clavien-Dindo classification.

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+5215537093156

dfcantu@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lennt N Gallardo-Alvarado, MD, Msc

Phone

+521553702118

dra.ngallardo@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Instituto Nacional de Cancerologia, Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

David Cantu de Leon

City

Mexico City

State/Province

Tlalpan

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Active, not recruiting

Facility Name

Instituto Nacional de Cancerologia

City

Mexico City

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David F Cantu de Leon, MD, PhD

Phone

525556280400

Ext

21016

dfcantu@gmail.com

First Name & Middle Initial & Last Name & Degree

Lenny N Gallardo-Alvarado, MD, MSc

Phone

525556280400

Ext

37000

dra.ngallardo@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

2 years

IPD Sharing 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.

Learn more about this trial

Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

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