NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Cervical Cancer FIGO Stage IB2 and IIB (NACOPRAD)

Charité University Medicine Berlin

Status and phase: Not yet enrolling; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: Carboplatin; Drug: Ifosfamide; Radiation: Radiation; Drug: Paclitaxel; Drug: Cisplatin; Procedure: hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02422563

NACOPRAD_2015

Details and patient eligibility

About

Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.

Full description

The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.

Enrollment: 534 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years
• cervical cancer FIGO IB2, IIB,
• squamous cell, adeno or adenosquamous cell carcinoma
• informed consent

Exclusion criteria

• small cell/neuroendocrine component
• previous radiation, previous cancer
• pregnancy
• HIV
• severe co-morbidities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

534 participants in 2 patient groups

Arm A: NACT+radical hysterectomy

Experimental group

Description:

Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy

Treatment:

Drug: Carboplatin

Procedure: hysterectomy

Drug: Ifosfamide

Drug: Paclitaxel

Drug: Cisplatin

Arm B: Chemoradiation

Other group

Description:

Arm B includes patients undergoing primary cisplatin based chemo-radiation

Treatment:

Drug: Cisplatin

Radiation: Radiation