Comparing Study Between Concurrent Chemoradiation and New Combination Treatment in Cervical Cancer Patients (TGOCphaseIII)

Thai Gynecologic Oncology Collaborative Group

Status and phase: Unknown; Phase 3

Conditions: Cervical Cancer

Treatments: Other: Neoadjuvant chemotherapy followed by surgery

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01000415

ECPSU-522231012

TGOC-03

Details and patient eligibility

About

The purpose of this study is:

• to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb)
• to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

Full description

According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium must not to pelvic wall. These were the common stages in Thai cervical cancer patients,and made a troublesome effect to Thai women. According to this study,stage early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. This specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- PR) and concurrent chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR. However in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.

Enrollment: 824 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cervical cancer patients with FIGO stage Ib2-early IIb
• Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma
• ECOG performance status 0-1
• No previous treatment for cervical cancer
• Acceptable hematological,renal,liver function

Exclusion criteria

• Previous history of cancer
• Underlying disease not fit for surgery
• Psychological problem
• Obvious pelvic/para-aortic node involvement
• Pregnancy
• HIV positive
• History of bowel obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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824 participants in 1 patient group

Cisplatin plus gemcitabine

Experimental group

Description:

Experimental arm: neoadjuvant chemotherapy (cisplatin plus gemcitabine) followed by surgery Control arm: concurrent chemoradiation (cisplatin/carboplatin)during standard radiation

Treatment:

Other: Neoadjuvant chemotherapy followed by surgery