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

  • STATUS
    Recruiting
  • participants needed
    824
  • sponsor
    Thai Gynecologic Oncology Collaborative Group
Updated on 8 November 2020
cancer
carcinoma
squamous cell carcinoma
chemoradiotherapy
carboplatin
gemcitabine
adenocarcinoma
concurrent chemoradiation

Summary

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)

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.

Details
Condition Cervical Cancer
Treatment Neoadjuvant chemotherapy followed by surgery
Clinical Study IdentifierNCT01000415
SponsorThai Gynecologic Oncology Collaborative Group
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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
Clear my responses

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