A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Adjuvant Chemotherapy; Lymph Node Metastases; Radiation; Cervical Cancer

Treatments: Drug: Paclitaxel, Cisplatin; Radiation: chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03468010

B2017-105-01

Details and patient eligibility

About

Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.

Full description

1. Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.
2. Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .
3. Patients

A patient will be enrolled when patient have:

1. Pathologically diagnosed cervical cancer;

2. pelvic or para-aortic lymph metastases, at least match one of following

   • CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
   • pelvic or para-aortic lymph node shows necrosis or extra capsular spread
   • PET/CT scan finds positive pelvic or para-aortic node lymph node
   • biopsy confirms lymph metastase

3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;

4. Karnofsky Performance Scores ≥ 70;

4.Method

1. Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, observation is given after radiation with concurrent cisplatin. But in Group B, three cycles of adjuvant chemotherapy ( Paclitaxel plus Cisplatin) are administered after radiation with concurrent cisplatin. The regimen of adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.The Grade 3/4 adverse events (CTCAE criteria ver. 4.03), the 3-year progression-free survival of the 2 groups, the 5-year overall survival of the 2 groups are compared.
2. In Group A and Group B, both the radiation method and the regimen of concurrent chemotherapy are the same.The gross tumor volume (GTVnd) is the lymph node lesion and given a dose of 60Gy. The clinical target volume (CTV) is according to the lymph drainage pathway and given a dose of 45Gy. The regimen of concurrent chemotherapy is Cisplatin 80mg/m2 once three weeks.

Enrollment: 432 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically diagnosed cervical cancer;

2. pelvic or para-aortic lymph metastases, at least match one of following

   • CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
   • pelvic or para-aortic lymph node shows necrosis or extra capsular spread
   • PET/CT scan finds positive pelvic or para-aortic node lymph node
   • biopsy confirms lymph metastase

3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;

4. Karnofsky Performance Scores ≥ 70;

Exclusion criteria

1. Patients with distant metastasis before or during radiotherapy
2. Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
3. Severe neurological, mental or endocrine diseases
4. History of other malignancies
5. Those who are considered by the researchers unsuitable to participate -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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432 participants in 2 patient groups

The control group (Group A)

Active Comparator group

Description:

In Group A, observation is given after chemoradiation

Treatment:

Radiation: chemoradiation

The experiment group (Group B)

Experimental group

Description:

in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.

Treatment:

Drug: Paclitaxel, Cisplatin

Radiation: chemoradiation