Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

Mei Shi

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Toxicity Due to Radiotherapy; Cervical Cancer

Treatments: Drug: docetaxel plus cisplatin; Radiation: Radiation; Drug: cisplatin（DDP） weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT01999933

XJFL-201309-CCPOSTOP

Details and patient eligibility

About

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

Full description

To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 Years to 70 Years
• Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
• Accepted radical hysterectomy 3-4 weeks before
• Karnofsky score >70
• Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.
• Examination results showed no radiation or chemotherapy contraindication
• Willing to accept treatment
• Ability to comply with trial requirements

Exclusion criteria

• Postoperative residual
• Postoperative recurrence or metastasis
• Without lymph node dissection
• Postoperative pathology showed aortic lymph node metastasis
• Examination results showed radiotherapy contraindications
• No indications for radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

CCRT with cisplatin(DDP) weekly

Active Comparator group

Description:

concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation

Treatment:

Radiation: Radiation

Drug: cisplatin（DDP） weekly

CCRT with TP

Experimental group

Description:

concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation

Treatment:

Drug: docetaxel plus cisplatin

Radiation: Radiation

Drug: docetaxel plus cisplatin

concurrent and adjuvant TP

Experimental group

Description:

2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation

Treatment:

Drug: docetaxel plus cisplatin

Radiation: Radiation

Drug: docetaxel plus cisplatin