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Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

Primary Purpose

Uterine Cervical Neoplasms

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Prophylactic extended-field Irradiation

Pelvic irradiation

Intracavitary brachytherapy

Concurrent chemotherapy

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Uterine Cervical Neoplasms, Extended-field irradiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment.
Age ≥18 years and ≤ 70 years.
Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.*
No evidence of distant metastasis (FIGO stage IVB).
At least meet one of the following characteristics:
1. Number of pelvic MLNs ≥ 2;
2. Short diameter of pelvic MLNs ≥ 1.5cm; *
3. Parametrial involvement to the pelvic wall ＃.
Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2.
Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L.
Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN).
- MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI.
  - Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;

Exclusion Criteria:

With common iliac MLNs.
Tumor extended to the lower third of the vagina.
Tumor spread to mucosa of the bladder or rectum.
Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
Prior malignancy.
History of previous radiotherapy to the abdomen or pelvis.
Pregnancy or lactation.
Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.
Active infection with fever.
Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.
Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

Sites / Locations

Peking Union Medical College HospitalRecruiting
First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pelvic Irradiation

Prophylactic EFI

Arm Description

Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, and pelvic lymph nodes regions. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with IMRT.

Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, pelvic lymph nodes regions and para-aortic lymph nodes region. The upper border of CTV is at the level of renal vessels. A dose of 45-50.4Gy is delivered to CTV with IMRT.

Outcomes

Primary Outcome Measures

Progression-free survival

Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

Secondary Outcome Measures

Overall survival

Overall survival is calculated from randomization to death from any cause.

Distant failure-free survival

Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first.

Para-aortic lymph nodes failure rate

The incidence of para-aortic lymph nodes failure.

Acute toxicity evaluated with CTCAE 5.0

Evaluated with CTCAE 5.0

Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Full Information

NCT ID

NCT03955367

First Posted

May 11, 2019

Last Updated

February 6, 2022

Sponsor

Peking Union Medical College Hospital

Collaborators

Peking University First Hospital, Cangzhou Central Hospital, The Second Affiliated Hospital of Dalian Medical University, Tumor Hospital of Gansu, First Affiliated Hospital of Guangxi Medical University, Harbin Medical University Third Affiliated Hospital, Wuhan Union Hospital, China, First Affiliated Hospital of Chongqing Medical University, Guizhou Provincial People's Hospital, Second Hospital of Jilin University, China-Japan Union Hospital, Jilin University, Jilin Provincial Tumor Hospital, Jiangsu Cancer Institute & Hospital, The 940th Hospital of Joint Logistics Support Force，PLA., General Hospital of Benxi Iron & Steel Industry Group, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Beijing Obstetrics and Gynecology Hospital, Tangshan People's Hospital, Zhongnan Hospital of Wuhan University & Second Clinical Hospital of Wuhan University, Second Affiliated Hospital of Xi'an Jiaotong University, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Tumor Hospital of Xinjiang Medical University, Zhejiang Cancer Hospital, The First Affiliated Hospital of Zhengzhou University, Affiliated Cancer Hospital of Zhengzhou University, Seventh Medical Center of PLA Army General Hospital, Shengjing Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Xiangya Hospital of Central South University, Henan Provincial People's Hospital, Xi'an Gaoxin Hospital, West China Second University Hospital, The Forth Affiliated Hospital of Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03955367

Brief Title

Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

Official Title

Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

Detailed Description

This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival.

6. Conditions and Keywords

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

Uterine Cervical Neoplasms

Keywords

Uterine Cervical Neoplasms, Extended-field irradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

638 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pelvic Irradiation

Arm Type

Active Comparator

Arm Description

Arm Title

Prophylactic EFI

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Prophylactic extended-field Irradiation

Other Intervention Name(s)

Prophylactic radiotherapy for para-aortic lymph nodes region

Intervention Description

CTV covers pelvis and para-aortic lymph nodes region.

Intervention Type

Radiation

Intervention Name(s)

Pelvic irradiation

Other Intervention Name(s)

Pelvic radiotherapy

Intervention Description

CTV covers pelvis.

Intervention Type

Radiation

Intervention Name(s)

Intracavitary brachytherapy

Other Intervention Name(s)

Brachytherapy

Intervention Description

The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.

Intervention Type

Drug

Intervention Name(s)

Concurrent chemotherapy

Other Intervention Name(s)

Chemotherapy

Intervention Description

Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival is calculated from randomization to death from any cause.

Time Frame

3-year

Title

Distant failure-free survival

Description

Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first.

Time Frame

3-year

Title

Para-aortic lymph nodes failure rate

Description

The incidence of para-aortic lymph nodes failure.

Time Frame

3-year

Title

Acute toxicity evaluated with CTCAE 5.0

Description

Evaluated with CTCAE 5.0

Time Frame

From the start of treatment to 3 months after treatment.

Title

Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Description

Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Time Frame

3-year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment. Age ≥18 years and ≤ 70 years. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al. No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.* No evidence of distant metastasis (FIGO stage IVB). At least meet one of the following characteristics: Number of pelvic MLNs ≥ 2; Short diameter of pelvic MLNs ≥ 1.5cm; * Parametrial involvement to the pelvic wall ＃. Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2. Adequate marrow: neutrophile granulocyte count ≥1.5*10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100*10^9/L. Normal liver and kidney function: Creatinine (Cr) < 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 2*upper limit of normal (ULN). MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI. Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI; Exclusion Criteria: With common iliac MLNs. Tumor extended to the lower third of the vagina. Tumor spread to mucosa of the bladder or rectum. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes. Prior malignancy. History of previous radiotherapy to the abdomen or pelvis. Pregnancy or lactation. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer. Active infection with fever. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

Central Contact Person:

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

Ke Hu

Phone

+86-01069155487

huk@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ke Hu

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ke Hu, MD

Phone

010-69155482

huk@pumch.cn

First Name & Middle Initial & Last Name & Degree

Weiping Wang, PhD

Phone

010-69155483

jluwangweiping@163.com

Facility Name

First Affiliated Hospital Xi'an Jiaotong University

City

Xi'an

State/Province

Shanxi

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zi Liu

12. IPD Sharing Statement

Citations:

PubMed Identifier

30153215

Citation

Wang W, Liu X, Meng Q, Zhang F, Hu K. Prophylactic Extended-Field Irradiation for Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Propensity-Score Matching Analysis. Int J Gynecol Cancer. 2018 Oct;28(8):1584-1591. doi: 10.1097/IGC.0000000000001344.

Results Reference

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Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

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